Associate Director RA & QA

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada.
• The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.
• This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.
• The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.

Responsibilities:

Regulatory Strategy & Leadership

• Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.
• Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.
• Ensure regulatory considerations are integrated into R&D, clinical, CMC, and commercial planning.
• Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.
• Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.

Health Canada Engagement & Regulatory Submissions

• Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.
• Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)
• Supplemental ANDS (SANDS)
• Notifiable Changes
• Post-approval regulatory filings
• Manage Health Canada deficiency responses, clarification requests, and review cycles.
• Coordinate cross-functional teams to ensure high-quality regulatory dossiers
• Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.
• Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.

In-Licensing & Regulatory Due Diligence

• Conduct regulatory due diligence for potential in-licensing and partnership opportunities.
• Evaluation of regulatory pathways and submission feasibility
• Data package completeness
• Bioequivalence strategy
• Intellectual property and exclusivity considerations
• Estimated approval timelines and risks
• Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.
• Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.

Portfolio Management & Lifecycle Optimization

• Support portfolio maximization (PMX) initiatives, including o Label expansions
• New strengths and dosage forms
• Site transfers
• Manufacturing changes
• Competitive lifecycle strategies
• Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.
• Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.

Cross-Functional Collaboration

• Work closely with internal teams including o R&D / Formulation Development
• Clinical & Bioequivalence
• Quality Assurance / Quality Control
• CMC / Manufacturing
• Intellectual Property
• Business Development
• Provide regulatory input during product development milestones and technical reviews.
• Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.

Team Leadership & Development

• Lead, mentor, and develop 1–3 regulatory associates/managers.
• Oversee work allocation, submission timelines, and performance development.
• Build a high-performance regulatory function capable of managing increasing submission volume.
• Promote a culture of accountability, quality, and regulatory excellence.

Requirements:

Education & Experience

• Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.
• Regulatory certification (e.g., RAC) is considered an asset.
• 15–20 years of regulatory affairs experience within the pharmaceutical industry.
• Extensive experience with Canadian regulatory submissions, particularly:
• ANDS
• SANDS
• eCTD filings
• Demonstrated experience interacting directly with Health Canada.
• Strong understanding of Generic drug approval pathways
• Bioequivalence requirements
• CMC regulatory expectations
• Experience supporting business development or in-licensing regulatory evaluations.
• Previous team leadership or mentoring experience preferred.

Core Competencies

• Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.
• Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.
• Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners
• Physical Requirements

Physical & mental requirements:

• Business travel (15% of time), driving as part of work responsibilities.