Regulatory Affairs Manager

Product Stewardship Communications Specialist

Regulatory Affairs Professional (Product Regulatory Expert)

Director of Regulatory Affairs

R&D Manager

Product Stewardship Specialist

Specialist, DEA Compliance

Senior Manager - Characterization R&D - Extractables & Leachables

Head of Security Management

Field Safety Compliance

Responsibilities: Key Functions: <ul><li>Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products.</li><li>Responsible to maintain local SOPs and ensure compliance with regulations are met.</li><li>Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.</li><li>Provide support to commercial team from regulatory perspectives.</li><li>Poison License Holder, company pharmacist.</li><li>Primary contact with Regulatory Authority Department in the country.</li></ul> Regulatory : <ul><li>Product scope includes new molecules, generics, biosimilars, medical devices, diagnostics and OTC.</li><li>Lead local regulatory work for pharma division including new product/ device registrations, variations and renewals.</li><li>Conduct regulatory related submission/ correspondence with respective local health authorities (National Pharmaceutical Regulatory Agency NPRA and Medical Device Authority MDA).</li><li>Develop registration strategies, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives.&nbsp;</li><li>Review, analyze and coordinate data for new product submissions, line extensions according to priorities. Ensure up-to-date product registration, variation, line extension and other related law &amp; regulations knowledge.</li><li>Ensure that the content complies with government regulations prior to submission to Regulatory Authority.</li><li>Maintain an awareness of country’s regulatory legislation and assess its impact on company’s business.</li><li>Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.</li><li>Maintenance of regulatory related database and licences such as product technical files, product complaints and adverse drug reaction records, import and poison A licences, etc.</li></ul> Local SOPs and Policies : <ul><li>Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with NPRA and MDA requirements.</li><li>Lead applicable regulations and standards including cGMP and Safety; Compliance topics and quality systems such as GDP, Change Control, Data Integrity, auditing, and Complaint Handling.&nbsp;</li></ul> Support Marketing Activities : <ul><li>Conduct strategy meetings with commercial team to discuss product pipelines and registration plans.</li><li>Provide management with a monthly registration status.</li><li>Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.</li><li>Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.</li></ul> Pharmacovigilance (PV) and Quality Assurance (QA) Support : <ul><li>Lead local pharmacovigilance system in line with local regulatory requirements.&nbsp;</li><li>Drive maintenance and preparation of local quality management system and internal audit in compliance to local regulatory requirements,</li></ul> Requirements: Qualifications : <ul><li>Bachelor’s degree in pharmacy.</li><li>Registered pharmacist recognized by MOH Malaysia.</li><li>Experience in regulatory affairs in a pharmaceutical or medical device company.</li><li>Familiar with local regulatory bodies such as NPRA and MDA.</li><li>Strong initiative and ability to take lead on projects.</li></ul>

Responsibilities: <ul><li>Assists in the planning, development, maintenance, and implementation of the SDS authoring process.</li><li>Partners across all areas of expertise within the PSRA organization to monitor, promote, and deliver high quality, and fully compliant SDSs.</li><li>Identifies key measures to assist in driving continuous improvements and adherence to applicable regulatory requirements.</li><li>Actively fosters an organizational culture that is based on collaboration, partnership, innovation, customer service, driving change, and teamwork.</li><li>SDS and label data maintenance for new and existing products, intermediates and experimental products. Position works under direct supervision as needed.</li><li>Maintain regulatory and compositional information from raw materials suppliers and our businesses.</li><li>Manage our translation process with a 3rd party vendor.</li><li>Enter and maintain hazard assessment and regulatory data into product compliance support and MSDS authoring systems.</li><li>Provide internal and external customer support related to hazard communication including SDS distribution.</li><li>Actively participate in projects to continue to maintain compliance with global hazard communication regulations and related regulatory requirements.</li><li>Use product compliance tools to retrieve/query production models, specifications, recipes, labeing information, global database searches.</li><li>Support company Product Stewardship and Regulatory Affairs activities.</li><li>Assist in special assignments and accepting new responsibilities as needed.</li><li>Contribute to group projects by offering proposed solutions to problems and methods to accomplish the goals of the Product Stewardship and Regulatory Affairs Group</li></ul> Requirements: <ul><li>Associate’s degree in Chemistry, Biological Sciences, Toxicology or HSE related field, computer technologies or equivalent experience in these fields.</li><li>Minimum 5 years of experience, desired.</li><li>Ability to multi-task and adapt to changing work priorities in a dynamic environment</li><li>Strong interpersonal skills required to facilitate team building and partnering with colleagues and peers</li><li>Demonstrated ability to focus on details, work autonomously and lead projects</li><li>Knowledge of computers, word processing and spreadsheet software. </li><li>Candidate will function using systems such as SAP, Sharepoint and Microsoft Office applications.</li><li>SAP EHS module experience a plus.</li><li>Results driven with excellent communication skills</li><li>Ability to handle multiple tasks/priorities and deal with ambiguity to meet specified deadlines.</li><li>Good analytical, problem solving and organizational skills.</li><li>Self-motivated, detail-oriented and comfortable working in a team environment.</li><li>Experience with innovative methodology for capturing and identifying metrics of key performance indicators.</li></ul>

Responsibilities: <ul><li>Work closely with Quality Assurance to obtain regulatory documentation required to maintain drug master files (DMFs)</li><li>Prepare and submit annual updates and amendments for DMFs to global regulatory agencies in accordance with the regulatory agencies’ guidelines.</li><li>Engage with and monitor external consultants utilized for submissions.</li><li>Track regulatory submissions to ensure timely filings in accordance with regional regulatory requirements.</li><li>Maintain regulatory records, including archiving of regulatory submissions.</li><li>Work closely with Product Stewards, Quality and project teams to outline regulatory requirements, costs, and timelines for new DMFs required to support new or expanding products.</li><li>Acquire in-depth knowledge of company current and developing portfolio of products used in the regulated markets mentioned above in order to answer compliance related questions from internal partners,</li><li>external parties, and add value to existing and new customer engagement discussions.</li><li>Maintain awareness of global regulatory legislation and its impact on company products and business</li><li>Provide appropriate information to promote the safe use of company products throughout their entire life-cycle to:</li><li>External Stakeholders – including customers, distributors, and industry partners</li><li>Internal Stakeholders - including Product Stewards and SMEs, manufacturing, technology, product management, and sales &amp; marketing personnel</li><li>Develop/maintain a sound awareness of global trends in pharmaceutical regulations.</li><li>Prepare responses for customer inquiries.</li><li>Execute reviews/approvals for new product reg tox and commercialization requests related to applications in regulated markets.</li><li>Assist with special projects related to Product Stewardship &amp; Regulatory Affairs, as needed.</li><li>Learn other areas within the Food, Drug, Device, Cosmetic (FDDC) Regulations to provide support to the FDDC team.</li></ul> Requirements: <ul><li>Minimum of Bachelor’s degree (or higher) required.</li><li>2 – 5+ years of experience in a regulatory affairs role.</li></ul>

Responsibilities: <ul><li>Develop and Execute Global Regulatory Strategy: Lead the development of a comprehensive global regulatory strategy for cultivated seafood products. This includes deep analysis of existing frameworks, anticipation of future regulatory developments, and proactive engagement with regulatory bodies in key markets.</li><li>Navigate Complex Landscape: Stay abreast of the evolving regulatory landscape across different countries and regions, identifying potential challenges and opportunities for product approvals.</li><li>Internal Regulatory Expert: Lead internal strategy around development of theory of safety, definition of required supporting data, and coordination of internal team resources to support regulatory advancement. Advise cross-functional teams on regulatory considerations, ensuring compliance throughout product development, manufacturing, and commercialization.</li><li>Lead Regulatory Submissions: Direct the preparation and submission of high-quality regulatory dossiers (e.g., novel food applications, pre-market notifications) in collaboration with internal and external stakeholders.</li><li>Stakeholder Engagement: Build strong relationships with key regulatory agencies, industry associations, and relevant government bodies globally. Facilitate discussions with strategic suppliers and customers to help them understand our regulatory requirements and their roles in implementation. Foster collaborative dialogue to advocate for science-based regulatory approaches.</li><li>Contribute to Regulatory Landscape: Participate in industry working groups and policy discussions to shape the future of cultivated meat regulations.</li><li>Drive Continuous Improvement: Stay informed of the latest scientific advancements and regulatory trends. Recommend updates to the companys regulatory strategies and best practices.</li></ul> Requirements: <ul><li>5+ years in highly regulated fields, especially novel foods</li><li>Experience with dossier prep and novel food approval across multiple global jurisdictions</li><li>Familiarity with regulatory frameworks in several key markets, including US, EU, China, and Japan (preferred)</li></ul> Skills <ul><li>Highly-skilled technical communicator – able to translate internal science-based evaluations to regulators in a clear, understandable, and persuasive manner and translate regulatory requirements into technical endpoints for R&amp;D team</li><li>Original thinker – proven ability to develop novel approaches and strategies to address challenging technical questions</li><li>Proven ability to coordinate work across multiple teams to produce data and narratives required for regulatory submissions and to ensure timely delivery of submissions</li></ul>

Job Description: <ul><li>As the R&amp;D Manager, you will be responsible for leading our Research and Development team in the creation and development of new food products and the improvement of existing ones.&nbsp;</li><li>You will play a key role in driving innovation, ensuring product quality, and maintaining regulatory compliance.</li></ul> Responsibilities: <ul><li>Lead the development and execution of the companys R&amp;D strategy in alignment with business objectives and market trends.</li><li>Manage and mentor a team of food scientists, technologists, and technicians, providing guidance and support to foster their professional growth and development.</li><li>Oversee all aspects of product development from concept to commercialization, including formulation, sensory evaluation, and scale-up.</li><li>Collaborate closely with cross-functional teams, including Marketing, Operations, Quality Assurance, and Regulatory Affairs, to ensure successful product launches and ongoing support.</li><li>Stay abreast of industry trends, emerging technologies, and consumer preferences to identify opportunities for innovation and differentiation.</li><li>Manage R&amp;D budget and resources effectively to optimize productivity and drive cost efficiencies.</li><li>Ensure compliance with regulatory requirements and food safety standards throughout the product development process.</li><li>Foster a culture of creativity, collaboration, and continuous improvement within the R&amp;D team.</li></ul> Requirements: <ul><li>Bachelors degree in Food Science, Food Technology, or related field required; Masters degree preferred.</li><li>Minimum 5 years of experience in R&amp;D leadership roles within the food industry, with a proven track record of successful product development and innovation.</li><li>Strong knowledge of food chemistry, ingredient functionality, and food processing technologies.</li><li>Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously.</li><li>Exceptional leadership and team-building skills, with the ability to inspire and motivate team members to achieve their full potential.</li><li>Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders.</li><li>Knowledge of regulatory requirements and quality standards relevant to the food industry.</li><li>Creative problem-solving skills and a passion for innovation in food product development.</li></ul> Benefits: <ul><li>Competitive salary commensurate with experience</li><li>Comprehensive benefits package including health insurance, retirement plans, and more</li><li>Opportunities for professional development and career advancement</li><li>A dynamic and collaborative work environment</li></ul>

Responsibilities : <ul><li>Relationship management (internal and external):&nbsp;</li><li>Build close relationships with regional businesses, technology personnel, other&nbsp;supporting functions, assigned regional PSRA for specific businesses and the&nbsp;Global PSRA team.</li><li>Develop and document business specific PSRA objectives and ensure regular&nbsp;communication on risks, needs, priorities and agreed actions.</li></ul> Regulatory understanding and leveraging:&nbsp;<ul><li>Develop deep understanding of specific product lines.</li><li>Enforce PSRA processes and follow global chemical management procedure to ensure regulatory compliance and lead business growth projects in SEA &amp; India.</li><li>Identify and communicate the critical regulatory/customer issues that will drive change. Provide practical solutions to businesses and our India-based Technical&nbsp;</li><li>Center in addressing these changes.</li><li>Facilitate external communication of customer requests including Safety Data Sheets, labels and various regulatory questions via Customer Inquiry&nbsp;</li><li>Management system and business/ technology partners.</li><li>Engage PSRA colleagues in Europe and the United States. Share the latest regulatory trends with regional business units and follow up as needed.</li></ul> Project management:&nbsp; <ul><li>Lead/facilitate business growth &amp; advocacy plans with stakeholders, as appropriate.&nbsp;</li></ul> Advocacy:&nbsp;<ul><li>Network with key government agencies and trade associations as representative.</li><li>Monitor and lobby for new/upcoming legislation and/or regulations</li></ul> Requirements : <ul><li>Bachelors or Masters degree in chemistry, biology, or a relevant technical field</li><li>A minimum of 5 years’ experience in PSRA</li><li>Experience in product stewardship and/or project management is preferred</li><li>Association or government agency background is a plus</li></ul>

Role Description: <ul><li>The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.</li><li>Those matters include licenses, procurement, and movement of material, production, shipment and destruction.</li><li>Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.</li></ul> Responsibilities: <ul><li>DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at site</li><li>Reviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)</li><li>Maintains Know your Customer (KYC) information</li><li>Conducts year‐end and biennial inventory and report ARCOS quarterly reporting &amp; cycle count inventory via DEA website</li><li>Coordinates all movement of controlled substances from manufacturing through analytical testing</li><li>Liaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperwork</li><li>Maintains compliance of all DEA, State, and Board of Pharmacy registrations</li><li>Coordinates all controlled substance destruction with QC, Environmental, Health &amp; Safety and Logistic departments</li><li>Works with Security department to maintain facility upgrades to security systems</li><li>Power of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 forms</li><li>Responsible for submitting CII quota applications to DEA; maintain organized DEA files on related activities</li><li>Coordinates and documents DEA audits for sites and issues audit reports to management upon completion</li><li>Remains current on DEA regs in order to address organization business needs</li><li>Creates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.</li></ul> SOPs: <ul><li>Updates associated SOP’s related to job functions</li></ul> Supporting responsibilities:&nbsp; <ul><li>Back up to State Licensing associate</li><li>Participates and represents department at project meetings as required</li></ul> Requirements: Education &amp; Experience: <ul><li>Bachelor’s degree in a relevant field required</li><li>2+ years’ relevant work experience</li></ul> Experience with IQVIA SOM software preferred <ul><li>Working knowledge of GMP regulations and compliance issues</li><li>Strong knowledge of DEA and FDA regulations</li><li>Knowledgeable of production and production planning processes</li></ul>

Responsibilities: <ul><li>Sr. Manager, R&amp;D characterization is responsible for contributing to all phases of Extractable &amp; Leachable studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation.</li><li>Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports in English.</li><li>Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.</li><li>Ensure compliance in all research, data collection and reporting activities.</li><li>Supervise and direct the lab work for junior level executives.</li><li>Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.</li><li>Support the build out of the R&amp;D- E&amp;L laboratory.</li><li>Develop and enhance technical capability through training and on job experience.</li><li>Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs.</li><li>Key contributor during experimental study designs, execution and review/approval at IH &amp; CROs study.</li><li>Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience</li><li>Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.</li><li>Create innovative products/processes/methods through novel combinations of expertise within the organization.</li><li>Contribute to the long-term scientific strategy of the department.</li><li>Influence the regional external regulatory environment in the areas of Extractables &amp; Leachables,</li><li>Elemental Impurities, and Structure Elucidation.</li><li>Write technical reports and documenting development work.</li></ul> Requirements: <ul><li>15+ years of experience in Extractables &amp; Leachables R&amp;D.</li><li>The candidate needs to have strong exposure in dealing with complex E&amp;L Case studies.</li><li>Should have experience managing and leading teams.</li><li>Should hold a PhD, Masters or equivalent with strong exposure to the chemistry side of pharmaceuticals.</li></ul>

Job Purpose: <ul><li>Manage and lead a team of managers, technical and support staffs of IT Security Department in order to secure and control the systems, networks, applications and databases within The Banking Group of companies.</li></ul> Responsibilities: <ul><li>Oversee Group IIT Security Department for IT systems, networks, applications and databases</li><li>Develop and implement IT Security Strategy plan for Banking Group of companies</li><li>Propose and seek approval for IT Security budget (Capex and Opex)</li><li>Develop, maintain and implement IT Security Policy for Banking Group of companies</li><li>Strategize and reorganize IT Security Department in order to establish a proper process of “makers” and “checkers”.</li><li>Recommend and implement new IT Security initiative to secure corporate and customer sensitive information</li><li>Facilitate IT Risk to ensure effective IT risk identification, mitigation and monitoring</li><li>Participate in IT projects to provide advice on security and compliance requirements.</li><li>Manage compliance reviews of IT functions to ensure the state of compliance with legal and regulatory requirements, internal policies and standards.</li><li>Manage the network security review and penetration test exercise</li><li>Ensure manuals are timely reviewed and safe-keeping of all policies and procedures</li><li>Ensure IT audit reports from internal and external auditors are responded and IT audit issues are tracked and rectified within the agreed timeframe</li><li>Ensure compliance to mandates set out by electronic partners (VISA, Mastercard, AMEX and MEPS)</li><li>Evaluate and implement proper security tools (SIEM, IDMS, DLP, etc) in order to mitigate the weaknesses in manual security controls as well as to promote an effective and efficient administration</li></ul> Oversees security technology areas like: <ul><li>Firewalls</li><li>Internet surfing proxy servers</li><li>Intrusion detection</li><li>Advanced Persistency Threats</li><li>Anti DDOS solutions</li><li>Internet Fraud Solutions</li><li>Data Loss Protection solutions</li><li>Dual control of ID and passwords</li><li>Enterprise password vaults</li><li>Escalation of user privileges</li><li>ID management</li><li>Single sign on</li></ul>&nbsp;Managerial (team/group responsibilities) <ul><li>Manage &amp; provide leadership to a team of managers, technical &amp; support staffs</li><li>Decision maker at department level for all IT Security related matters</li><li>Provide guidance to IT Staff &amp; Business User in complying to regulatory &amp; audit requirement</li><li>Organizational (organizational responsibilities) including Strategic Cost Management and Financial Goals</li><li>Recommend &amp; implement security architecture for banking Group of companies</li><li>Support group wide IT Security requirement (Singapore, Vietnam, Hong Kong, Insurance &amp; Investment Banking)</li><li>Update security statuses to Senior Management at IT Security/Risk Meeting</li></ul> Requirements: <ul><li>Education/Qualification - Degree/Higher Diploma in Computer Science/IT</li><li>Experience/Requirements - More than 10 years of supervisory and managerial experience in IT Security Department</li><li>Special Skills Interpersonal Skill , Leadership Skill &amp; Time and Resource Management Skill</li></ul> Certification/Licensing Requirements: <ul><li>Certified CRISC (Certified Risk Information Systems Control) by ISACA</li><li>Certified CHFI (Certified Hacking Forensic Investigator) by EC-Council</li><li>Certified ECSA/LPT (Certified Security Analyst) by EC-Council</li><li>Certified CEH (Certified Ethical Hacker) by EC-Council</li><li>Certified CISSP (Certified Information Systems Security Professional) by (ISC)2</li><li>Certified CISA (Certified Information System Auditor) by ISACA</li><li>Certified CISM (Certified Information Security Manager) by ISACA</li></ul>

Role Description: <ul><li>As one of the world’s largest fully integrated energy enterprises, our client looks for individuals who can meet and exceed our expectations.</li><li>Power Systems Technical Support Department is currently seeking an experienced Field Compliance Coordinator to join the Power Systems Department in Dhahran, Saudi Arabia.</li></ul> Responsibilities: <ul><li>Provide advice and consultation to department staff to assist them in maintaining a safe working environment in compliance with environmental/safety regulations, standards and practices.</li><li>Identify and evaluate hazardous conditions and practices in the workplace. Conduct surveys to identify and evaluate occupational health, safety and environmental conditions.&nbsp;</li><li>Conduct and coordinate on-site inspections to audit physical conditions and safe work practices.&nbsp;</li><li>Provide advice and counsel concerning compliance with corporate safety regulations and procedures.</li><li>Perform construction site and/or area safety inspections of department facilities and operations.&nbsp;</li><li>Perform job site safety compliance inspections, including hazard analyses and safe work procedures, and prepare written reports and recommendations.</li><li>Develop controls for identified hazards.&nbsp;</li><li>Coordinate the implementation of controls from the results of hazard analyses.&nbsp;</li><li>Measure and evaluate the effectiveness of the hazard control system, policies, and procedures and recommend changes that reflect improved opportunities to eliminate work place incidents and injuries.</li><li>Prepare safety orientations, safety training and job site inspection procedures. Direct or assist in the development of specialized education and training materials. Conduct specialized safety and environmental training programs to communicate hazard control information.&nbsp;</li><li>Assist local management in new employee occupational health, safety and environmental orientation.</li><li>Participate in Safe Operations Committee meetings.</li><li>Review and analyze injury, property damage, and statistical loss data and work with management to prepare comprehensive recommendations for corrective action to eliminate or minimize potential hazards.</li><li>Incorporate essential safety requirements in all purchasing and contracting actions.&nbsp;</li><li>Recommend the purchase of safety equipment, related supplies, and personal protective equipment (PPE) in accordance with established company requirements.</li><li>Maintain awareness of corporate safety and environmental requirements and make recommendations for their implementation.</li><li>Assist management with monitoring adherence to department safety and environmental programs by employees and contractors.</li></ul> Requirements: <ul><li>As the successful candidate you will have a bachelor’s degree in engineering, safety engineering, industrial hygiene, environmental science or a related field.</li><li>You will have nine years of related safety/operational experience and/or training, preferably in the oil/gas or petrochemical industry, or in power distribution.</li><li>You must have knowledge or training in occupational health, safety and environmental compliance within power systems.</li></ul>

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225 regulatory compliance Jobs found

Regulatory Affairs Manager

Product Stewardship Communications Specialist

Regulatory Affairs Professional (Product Regulatory Expert)

Director of Regulatory Affairs

R&D Manager

Product Stewardship Specialist

Specialist, DEA Compliance

Senior Manager - Characterization R&D - Extractables & Leachables

Head of Security Management

Field Safety Compliance

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225 regulatory compliance Jobs found

Regulatory Affairs Manager

Product Stewardship Communications Specialist

Regulatory Affairs Professional (Product Regulatory Expert)

Director of Regulatory Affairs

R&D Manager

Product Stewardship Specialist

Specialist, DEA Compliance

Senior Manager - Characterization R&D - Extractables & Leachables

Head of Security Management

Field Safety Compliance

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.