Senior Manager External Affairs

VP – Compliance Risk Management Officer

Quality Assurance Specialist/Engineer

Compliance Officer

Senior Compliance Manager

Senior Certification Engineer (HOA)

Compliance Analyst 

Basel III RWA Remediation - Vice President

Senior Scientist - Analytical R&D

APAC Risk Management Legal Entity Oversight Coordinator

Responsibilities: <ul><li>Lead affiliate management in the development and implementation of an integrated regulatory, fiscal strategy in order to obtain stability, predictability and business growth.&nbsp;</li><li>Participate in advocacy engagements but not limited to political, bureaucratic and industry stakeholders, and other relevant opinion leaders to build allies/coalitions in support of tobacco harm reduction.&nbsp;</li><li>Support the education of internal stakeholders on regulatory/business environment and science behind companys RRP efforts</li><li>Provide support to regulatory affairs initiatives by regular update of regulatory dossier of tobacco industry &amp; tobacco control and best practices on regulatory anti-illicit trade issues as well as company views and positions in support of comprehensive tobacco control regulation focused on harm reduction to key stakeholders.</li><li>Provide expertise, knowledge, and advice to local management on current and emerging tobacco issues and the evolution of societal expectations in order to increase understanding on how these issues impact the overall business strategy to develop appropriate business strategies for long-term growth</li></ul> Requirements: <ul><li>Regulatory and government affairs experience required with sound knowledge of national government and legislative structure &amp; understanding of public/private sector dynamic</li><li>Solid Experience in government advocacy</li><li>Be capable to work (and influence) with different stakeholders in a unique complex business environment (internal and external</li><li>Demonstrate the ability to work sensitively, and effectively, within and across diverse teams</li><li>Be an entrepreneurial self-starter who comes up with new approaches and is eager to try those out</li></ul>

Responsibilities: <ul><li>Assist in the design, development, deliver a best-in-class Compliance Risk Reporting Framework, Standards and Procedures for reporting of compliance risk across Products/Functions/Material Legal Entities.</li><li>Support the design and implementation of the framework to identify key compliance risk reporting components, including compliance risks arising from third party performed activities.</li><li>Support the ICRM Regional bridge resources in execution of the Compliance Program Transformation action plan.</li><li>Serves as a subject matter expert on company’s Compliance Risk Reporting Framework, Standards and Procedures.</li><li>Providing oversight and guidance over the assessment of complex issues, structuring potential solutions and driving effective resolution with other stakeholders.</li><li>Identifying and assessing company’s key compliance risks. Ensuring compliance risks are effectively identified, measured, monitored, and controlled, consistent with the bank’s risk appetite statement and all policies and processes established within the risk governance framework.</li><li>Monitoring adherence to company’s Compliance Risk Policies and measuring compliance risk through a robust control framework and ensuring that reviews are conducted consistently across each entity on a regular basis to confirm that controls identified are operating effectively.</li><li>Performing complex analyses of comparative data, preparing and presenting regional and global reports related to compliance risk assessments, and monitoring of compliance related issues.</li><li>Partnering, collaborating and working with other areas, as necessary.</li><li>Keeping abreast of regulatory changes, new regulations and internal policy changes in order to further identify new key risk areas.</li></ul> Requirements : <ul><li>Knowledge of Compliance laws, rules, regulations, risks and typologies</li><li>Must be a self-starter, flexible, innovative and adaptive</li><li>Highly motivated, strong attention to detail, team oriented, organized</li><li>Strong presentation skills with the ability to articulate complex problems and solutions through concise and clear messaging</li><li>Excellent written and verbal communication and analytical skills</li><li>Ability to work collaboratively with regional and global partners in other functional units; ability to navigate a complex organization; to influence and lead people across cultures at a senior level</li><li>Awareness of regulatory requirements including local and US laws, international and industry standards</li><li>Comfortable acting as an agent for positive change with agility and flexibility</li><li>Effective negotiation skills, a proactive and no surprises approach in communicating issues and strength in sustaining independent views.</li></ul>

Job Role: <ul><li>The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry.&nbsp;</li><li>Our products are used, among other things, in the production of medical devices and controlled release medicines.&nbsp;</li><li>The products are developed and produced to customer specifications in our factories in Gorinchem, The Netherlands and Tucker, GA, USA.&nbsp;</li><li>This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.</li><li>The Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards.&nbsp;</li><li>This makes sure that our customers receive the consistent high quality product from our client that they have become accustomed to.</li></ul> Responsibilities: The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs.&nbsp;The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry.&nbsp;The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; ISO 13485 and other applicable regulations.&nbsp;As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products. <ul><li>Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.</li><li>Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.</li><li>Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.</li><li>Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.</li><li>Coordinate Quality and Regulatory Affairs relating to Drug Master Files (DMF) and Device Master Files (MAF) ensuring filings meet requirements of Regulatory Agencies and business needs.&nbsp;</li><li>Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.</li><li>Improve quality risk management procedures to ensure periodic review and performance reporting.</li><li>Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.</li><li>Perform annual product reviews for commercial products.</li><li>Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s or Masters degree in Chemistry, Engineering, Life Sciences or other relevant area.</li><li>Minimum 2 years of experience as a Quality Engineer in pharmaceutical, medical device or other related industries.</li><li>Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.</li><li>Experience with Commissioning, Qualification and Validation activities for new production equipment.</li><li>Experience in applying Quality Risk Management principles and tools (ICH Q9, HACCP, FMEA, HAZOP, etc.).</li><li>Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, ISO 13485 and other applicable regulations.</li><li>Strong written and verbal communication skills, in English and preferably in Dutch.</li><li>Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).</li><li>Proven ability to work cross-functionally to achieve business outcomes.</li><li>Attention to detail, commitment to quality, accuracy, efficiency, and consistency.</li><li>Ability to travel occasionally as determined by business requirements.</li></ul>

Role Description: <ul><li>Division / Department :Audit</li><li>The Compliance Officers objective is to ensure that the organization operates ethically and within legal and regulatory boundaries, while minimizing the risk of non-compliance and associated penalties.</li></ul> Responsibilities: <ul><li>Develop and implement policies and procedures to ensure compliance with relevant laws and regulations.</li><li>Conduct regular audits and risk assessments to identify potential compliance issues.</li><li>Provide guidance and training to employees on compliance matters.</li><li>Investigate and report any compliance violations or suspected violations.</li><li>Recommend corrective actions to address compliance issues and prevent future violations.</li><li>Keep up-to-date with changes in regulations and laws that may affect the organizations compliance obligations.</li><li>Work with other departments and stakeholders to ensure that compliance is integrated into all business processes.</li><li>Maintain records and documentation related to compliance activities.</li></ul> Requirements: <ul><li>5- 7 years of experience.</li><li>Must have experience with listed company.</li><li>Must have experience with investment /holding company.</li><li>Industrial / manufacturing is plus.</li><li>Arabic speaking.</li></ul>

Responsibilities:&nbsp; <ul><li>Provides leadership and development for hub unit QEH&amp;S team members, through teaching and coaching.&nbsp;</li><li>Drives successful attainment of regional QEH&amp;S goals, objectives and targets at the unit level.&nbsp;</li><li>Liaises with support functions such as Human Resources and Customer Service to evaluate and reduce potential risks.&nbsp;</li><li>Provides operating unit technical support in the areas of quality, food safety, occupational safety and health, chemical safety, waste management, waste water and storm water pollution prevention, air quality and environmental annual reporting.&nbsp;</li><li>Prepares proposals and reports for unit and regional leadership.&nbsp;</li><li>Ensures adherence to departmental budgets.&nbsp;</li><li>Liaises with unit customers, union representatives, airport and regulatory agencies to identify emerging trends and issues.&nbsp;</li><li>Implements special projects related to company business objectives related to the QEH&amp;S.&nbsp;</li><li>Assesses and ensures compliance with local, state and federal food safety, environmental, health and safety regulations.&nbsp;</li><li>Ensures regulatory reporting responsibilities of units are met.&nbsp;</li><li>Partners with units to integrate sustainable compliance solutions within operations.&nbsp;</li><li>Supports Environmental Compliance Calendars for assigned units.&nbsp;</li><li>Works with regulatory agencies and environmental consulting firms to achieve goals and ensure permits are in place.&nbsp;</li><li>Supports unit operations training in QEH&amp;S.&nbsp;</li><li>Drives waste minimization, reduction and recycling process through the identification of opportunities and targets.&nbsp;</li><li>Supports operating unit program implementation.&nbsp;</li><li>Supports operating units in determination of quality defects, accident and injury root causes, corrective and preventive actions.&nbsp;</li><li>Monitors, measures and communicates unit safety trends, targets and impacts through the use of QEH&amp;S scorecards.&nbsp;</li><li>Evaluates and continuously improves unit risk prevention process effectiveness (Business Management System (BMS), Critical Control Points (CCPs), Personal Responsibility in your Daily Efforts (PRIDE) and Ramp Safety, Quality and Delivery (SQUAD).&nbsp;</li><li>Works with operations leadership to optimize deployment of QEH&amp;S processes.&nbsp;</li><li>Administers corporate QEH&amp;S policies and procedures within hub units and make improvement recommendations.&nbsp;</li><li>In conjunction with Human Resources, identifies and supports implementation of CSR, health and wellness initiatives at the unit level.&nbsp;</li><li>Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI “Preventive Controls Qualified Individual according to company policy.&nbsp;</li><li>Completes all other company required training including but not limited to ServSafe Sanitation Manager Certification.&nbsp;</li></ul> Requirements: Education:&nbsp; <ul><li>Bachelor’s degree in Environmental Health and Safety or related field.&nbsp;</li><li>In exceptional cases, relevant and extensive work experience may substitute for the degree requirement.&nbsp;</li></ul>&nbsp;Work Experience:&nbsp;&nbsp; <ul><li>Minimum 5 years industrial experience in quality, environmental, health and safety&nbsp;</li><li>Airline and/or food industry experience preferred&nbsp;</li><li>A proven track record of successful results&nbsp;</li><li>Proven experience in field implementation of quality, environmental, health and safety processes.&nbsp;</li></ul>

Role description: <ul><li>Our airworthiness team plays a key role in bringing our vision to life.</li><li>It also represents a key intermediary interface between and the relevant aviation authorities who are responsible for the safety and certification of the products.</li><li>As well as helping to shape the regulatory environment according to which our products will be certified, your task will also be to support our in-house design teams.</li><li>By this you will contribute that our aircraft will meet the applicable certification standards and regulatory requirements.</li></ul> Responsibilities: <ul><li>Understanding and interpretation of Part 21 Sub. G and J.</li><li>Understanding and interpretation of the applicable CS and environmental protection requirements.</li><li>Understanding and uncompromised adherence to Design Organization procedures.</li><li>Assisting to quality assurance personnel in ensuring the Design Organization Handbook is up to date.</li><li>Supporting all departments of the design organisation in all questions regarding airworthiness, environmental protection approvals and certification.</li><li>Preparation of the Type Investigation program and co-ordination of all tasks related to Type Investigation in concurrence with EASA.</li><li>Co-operation in issuing guidelines for the preparation of the manuals required by the applicable implementing rules, Service Bulletins, drawings, specifications, and standards&nbsp;</li><li>Coordination with compliance verification engineers for satisfactory completion and showing of compliance against target certification specifications.</li><li>Co-operation in preparing test programs needed for demonstration of compliance.&nbsp;</li><li>Signing of conformity statements for test articles and components before performing laboratory, ground, or flight tests.&nbsp;</li><li>Approving the classification of changes in accordance with DOA privileges.&nbsp;</li><li>Monitoring of significant events on other aeronautical products as far as relevant to determine their effect on airworthiness of products being designed by the design organisation&nbsp;</li><li>Synchronising with EASA with regard to the issue of airworthiness directives in general based on Service Bulletins&nbsp;</li><li>Active involvement in internal DOA relevant training activities.</li></ul> Requirements: What do we expect from the candidate? <ul><li>Master’s degree in aerospace or aeronautical engineering or STEM + 10 years’ experience in aviation.</li><li>Knowledge of the EASA regulatory environment and EASA practices.</li><li>Previous involvement in EASA Type Certification Processes.</li><li>Knowledge of airworthiness code on national level (German LTF-UL, UK-BCAR) is beneficial.</li><li>Experience as Airworthiness Engineer and with Aviation safety (SMS).</li><li>Pragmatic and open-minded approach to novel technology design solutions.</li><li>Organizational and time management skills.</li><li>Technical problem-solving skills.&nbsp;</li><li>High level of communication skills.</li><li>Safety oriented mindset.</li><li>English language proficiency (at least C1).</li><li>German language proficiency is beneficial.</li></ul> What do we offer? <ul><li>Long-term involvement in the company.</li><li>Flexible working time.</li><li>Dynamic and interesting teamwork in a young team.</li><li>Work in a creative and ambitious international company.</li><li>Access to unique knowledge, information in the field of aviation, department, and professional training resources.</li><li>Opportunities for personal and professional development.</li></ul>

Responsibilities:&nbsp; <ul><li>Review and provide feedback on transactions escalated by processors related to various compliance regulations</li><li>Prepare /Submit Reports to respective business units and retain records of U.S Anti-boycott Regulations, Sanctions violations, U.S. Export Control, potential money laundering situations on a monthly/quarterly basis</li><li>Work closely with Global/Regional Compliance, Transaction Services Business Compliance Officer, CSIS and Legal Counsel on compliance matters (as deemed necessary)</li><li>Ensure timely update of Compliance Screening Procedures upon receipt of a communication from Global information sources.</li><li>Prepare annual compliance plan and training schedule to ensure yearly compliance training requirements are met</li><li>Update Compliance training materials to reflect the current trends;</li><li>Raise overall Compliance awareness by publication of bulletins, daily quizzes</li><li>Participate in internal and external audit reviews</li><li>Identify root cause analysis for compliance issues identified during Manager Control Assessment and undertake corrective action for immediate compliance</li><li>Contribute to process improvement measures to serve our internal clients better</li></ul> Requirements: <ul><li>Mandarin communication skills is required</li><li>A recognized tertiary qualification in Banking, Business, Finance, Economics, Accounting or Management.</li><li>Good PC software application knowledge.</li><li>Good communication and interpersonal skill.</li><li>Team player and able to work in highly challenging environment.</li><li>Ready to work in Flexible work timing</li><li>Good initiative / proactive.</li><li>Good presentation skills.</li><li>Ability to conduct training.</li><li>Relatively well versed with all aspects of trade compliance.</li></ul>

Job role: <ul><li>The role will be part of the Capital Controllers Transformation team (CCT), which is accountable to ensure timely delivery of regulatory commitments under the consent order milestones related to Credit and Market risks.&nbsp;</li><li>This role will be responsible for leading day-to-day execution of the remediation work required to meet commitments established in the OCC and FRB Consent Orders relating to Spot RWA, as well the remediation required for business as usual and other Supervisory issues related to RWA.&nbsp;</li></ul> Responsibilities: <ul><li>Accountable for successful and timely delivery of RWA milestones and deliverables per consent order and BAU remediation across relevant RWA exposures covering modeled and non-modeled components.&nbsp;</li><li>This may include market risk, wholesale, retail, counterparty credit risk and securitization.</li><li>Document and execute processes and controls, identify related gaps for calculation, aggregation and reporting (from authorized redistributors to reporting systems), including Standardized and Advanced Approaches, to demonstrate compliance with US Basel regulation and related supervisory guidance; and remediate any identified gaps through the ongoing issue management process</li><li>Define, develop, and establish robust control processes that can effectively demonstrate US Basel III regulatory capital requirements are applied in an accurate and appropriate manner.</li><li>Drive the diagnostics and remediation activities of a broad range of regulatory capital calculations that encompass governance, data and non-data controls, processes, system implementation and regulatory reporting.</li><li>Manage the project and coordination with relevant stakeholders to ensure adherence to consent order milestones and deliverables.</li></ul> Requirements: Experience with transformation roles in Financial Institutions and reasonable understanding of Advanced and Standardized US regulatory capital rules for any of the following: <ul><li>Counterparty Credit Risk (Derivatives/Secured Financing Transactions)</li><li>Retail and Wholesale Exposures</li><li>Market Risk</li><li>Securitization and Equity exposures</li><li>Ability to define, articulate and re-engineer complex processes and procedures, with appropriate controls, and think both strategically and tactically while driving meticulous execution</li><li>Exceptional oral communication and writing skills, with ability to synthesize complex concepts, and translate into "user-friendly" language for multiple audiences, including senior management, multiple internal constituents, and regulators</li><li>Solid data analysis skill including advanced knowledge of Microsoft Excel and Access (or other database front-end query applications).</li><li>Minimum 3-5 years’ experience in related field.</li><li>Education Level: Bachelor’s Degree</li></ul>

Responsibilities: <ul><li>Independently lead analytical method develop and validation activities for assigned ANDA products.</li><li>Develop and validate analytical methods for release and stability testing.</li><li>Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.</li><li>Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.</li><li>Resolve complex problems in method or product development.</li><li>Develop and understand product stability to guide design of stability studies in support of product registration.</li><li>Generate technical documents to support regulatory submissions.</li><li>Provide timely analytical support on deficiency responses and product approval inspections.</li><li>Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.</li><li>Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.</li></ul> Requirements: <ul><li>Peer review of lab notebooks.</li><li>Evaluate, troubleshoot/improve existing analytical methods when necessary.</li><li>Continuously update knowledge of latest technologies related to analytical science</li><li>Work in compliance with cGMP/cGLP regulations.</li><li>Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.</li><li>Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.</li><li>Strong knowledge of FDA, ICH, and USP guidance and regulations.</li></ul>

Role Description: <ul><li>The APAC Risk Management Legal Entity Oversight Coordinator role provides unique visibility and exposure to different countries, businesses, functions, products, and risk types.</li><li>The candidate will have significant interaction with the APAC CRO, senior management, and subject matter experts as well as direct responsibility for one of the most critical strategic projects in the region.</li></ul> Responsibilities: Key responsibilities are as follows. <ul><li>Establish and ongoing oversight of Legal Entity Risk Management Frameworks (RMF), Policy, Standards and Procedures in line with minimum baseline standards and local regulatory requirements for all applicable entities in APAC.</li><li>Establish and ongoing oversight of the Legal Entity Risk Appetite Framework (RAF), Policy, and Standards in line with minimum baseline standards for all applicable legal entities in APAC.</li><li>Ensure that dispensations are sought where minimum standards are not being met.</li><li>Oversee implementation of Risk Management Information (MI) tools.</li><li>Monitor and report all relevant risk categories and types against appetites set to the relevant committees and/or boards within the region in a timely fashion.</li><li>Perform gap analysis of Legal Entity capabilities against the baseline standards for RMF, RAF and MI for all applicable entities in APAC.</li><li>Establish the necessary remediation plans to ensure a path to green including any interim risk mitigation controls that may be required.</li><li>Participate in Risk MI tool development through the provision of detailed requirements to the development team, participation in UAT, gap analysis and remediation through to go-live in production.</li><li>Transition development of Legal Entity RMF, Legal Entity RAF, and MI to a BAU process including establishing any required annual review process for legal entities.</li><li>Engage with regional peers and central resources on ongoing development to ensure globally consistent approach for any required enhancements of Legal Entity capabilities.</li><li>Participate in Legal Entity tiering discussions (for relevant Legal Entities) including proposals to change tiers, ensuring implications are fully considered and appropriate steps are taken to meet minimum baseline standards.</li><li>Provide strategic analytics and information management to senior management. Responsible for communicating implications of existing Legal Entity-related regulations and developing potential responses.</li><li>Analyze new risk-related guidelines, best practice standards, rules and regulations. Provide updates, as needed, to management and regulators on exam and issue remediation status including progress against milestones, risk identified and any other potential impacts</li><li>Significant interaction with a wide range of senior bank and risk management colleagues, as well as external stakeholders such as regulators / auditors.</li><li>Initiate feedback sessions with global and legal entity teams; leverage feedback to influence change throughout organization.</li><li>Manage regulatory or Internal Audit examinations related to legal entities to achieve full compliance.</li><li>Appropriately assess risk when decisions are made, demonstrating particular consideration for the firms reputation and safeguarding its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency, as well as effectively supervise the activity of others and create accountability with those who fail to maintain these standards.</li></ul> Requirements: <ul><li>Bachelor’s/University degree, Master’s degree preferred.</li><li>10+ years Risk experience in a global organization, with experience in product program governance and risk management frameworks.</li><li>Strong knowledge of multiple risk categories spanning Financial (e.g., Market, Credit, Liquidity) and Non-Financial (e.g., Operational, Compliance, Reputation and Strategic).</li><li>Strong awareness of both bank (including Branch network) and broker dealer chains and their respective strategies, products, risk profiles and regulatory requirements in a global marketplace</li><li>Knowledge of applicable frameworks, policies, and standards.</li><li>Broad understanding of classifiable and delinquency managed credit and operational policies and procedures; ability to interpret financial and risk reporting.</li></ul>

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142 regulatory compliance Jobs found

Senior Manager External Affairs

VP – Compliance Risk Management Officer

Quality Assurance Specialist/Engineer

Compliance Officer

Senior Compliance Manager

Senior Certification Engineer (HOA)

Compliance Analyst

Basel III RWA Remediation - Vice President

Senior Scientist - Analytical R&D

APAC Risk Management Legal Entity Oversight Coordinator

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142 regulatory compliance Jobs found

Senior Manager External Affairs

VP – Compliance Risk Management Officer

Quality Assurance Specialist/Engineer

Compliance Officer

Senior Compliance Manager

Senior Certification Engineer (HOA)

Compliance Analyst

Basel III RWA Remediation - Vice President

Senior Scientist - Analytical R&D

APAC Risk Management Legal Entity Oversight Coordinator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.