Associate Director, Global Regulatory Strategy

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Oversee regulatory functions for clinical and commercial registrations in various global markets.

• Manage the regulatory portfolio for the PSMA franchise, encompassing new product development, registration approvals, and lifecycle management.

• Create and execute regulatory strategies for submissions related to clinical, commercial, and lifecycle management.

• Coordinate submissions for INDs, NDAs, MAAs, and other pertinent regulatory filings in collaboration with cross-functional teams.

• Lead the PSMA portfolio team, ensuring equitable workload distribution and adherence to timelines.

• Direct registration strategies and processes for the PSMA franchise.

• Serve as the regulatory lead for the PSMA portfolio, ensuring alignment with global regulatory standards.

• Conduct regulatory risk assessments and develop mitigation plans.

• Prepare and present strategies to regulatory authorities while maintaining communication with applicants and health agencies.

• Collaborate with teams in QA, Clinical Development, Research and Innovation, Commercial, Supply Chain, Quality, and Strategic initiatives.

• Guide regulatory portfolio planning and prioritization efforts.

• Advise senior management on regulatory risks and potential opportunities.

• Manage responses to inquiries from Health Authorities, variations, and compliance requirements post-market.

• Assist the Senior Director of Global Regulatory Strategy with international regulatory projects and strategic initiatives.

⛳️ Requirements

• A degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline (advanced degree preferred).

• Over 9 years of experience in Regulatory Affairs, including leadership roles.

• Extensive experience with clinical and commercial regulatory submissions, including CTAs, INDs, NDAs, MAAs, and post-market variations.

• In-depth knowledge of global regulatory frameworks, including FDA, EMA, TGA, PMDA, Health Canada, and Medsafe.

• Demonstrated ability to engage with regulatory agencies and lead successful interactions with health authorities.

• Strong understanding of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle management.

• Excellent communication skills to effectively interact with colleagues and stakeholders across all levels.

• Proven capability to work collaboratively as part of a team.

• Flexibility in a fast-paced environment and readiness to embrace new challenges.

• A commitment to ethical conduct and ongoing professional development.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Flexible hybrid and remote work arrangements.