Associate Director RA & QA

We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house talent acquisition teams. About our client 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. About the role 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. As a Associate Director RA & QA, you will be responsible for... Regulatory Strategy & Leadership Developing and implementing regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market. Providing strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy. Ensuring regulatory considerations are integrated into R&D, clinical, CMC, and commercial planning. Advising senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways. Leading regulatory planning for first-to-file, complex generics, and niche opportunities where applicable. Health Canada Engagement & Regulatory Submissions Serving as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities. Leading preparation and submission of: Abbreviated New Drug Submissions (ANDS) Supplemental ANDS (SANDS) Notifiable Changes Post-approval regulatory filings Managing Health Canada deficiency responses, clarification requests, and review cycles. Coordinating cross-functional teams to ensure high-quality regulatory dossiers Representing the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations. Tracking and interpreting Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals. Conducting regulatory due diligence for potential in-licensing and partnership opportunities. Evaluation of regulatory pathways and submission feasibility Bioequivalence strategy Intellectual property and exclusivity considerations Estimated approval timelines and risks Providing regulatory risk assessments and strategic recommendations to senior management during deal evaluation. Supporting technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio. New strengths and dosage forms Site transfers Manufacturing changes Competitive lifecycle strategies Identifying regulatory opportunities to extend product lifecycle or improve market competitiveness. Partnering with commercial, market access, and supply chain teams to align regulatory activities with business objectives. Cross-Functional Collaboration Working closely with internal teams including R&D / Formulation Development Clinical & Bioequivalence Quality Assurance / Quality Control CMC / Manufacturing Business Development Providing regulatory input during product development milestones and technical reviews. Ensuring regulatory compliance with Health Canada, ICH, and global regulatory standards. Leading, mentoring, and developing 1–3 regulatory associates/managers. Overseeing work allocation, submission timelines, and performance development. Building a high-performance regulatory function capable of managing increasing submission volume. Promoting a culture of accountability, quality, and regulatory excellence. What you already have... 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.

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