Associate Director Regulatory Affairs

ABOUT THE ROLE

We are looking for a seasoned and proactive Associate Director of Regulatory Affairs to join our leading client and lead the regulatory strategy for innovative Cell and Gene Therapy programs. In this role, you will take charge of shaping and executing regulatory strategies across all phases of development—from preclinical through clinical and into commercialization. You will collaborate closely with cross-functional teams, including R&D, clinical, manufacturing, and legal, ensuring  therapies meet regulatory standards and are positioned for successful approval and global market access.

Key Responsibilities:

• Lead the creation and execution of global regulatory strategies for cell and gene therapy products, managing all aspects of regulatory submissions and interactions with health authorities such as the FDA, EMA, PMDA, and others.

• Oversee and coordinate the preparation and submission of key regulatory filings, including IND applications, BLA, MAA, and other essential regulatory documents for cell and gene therapies.

• Continuously monitor and interpret evolving global regulatory policies and guidelines, providing strategic advice and solutions to address potential regulatory challenges, risks, and requirements specific to cell and gene therapies.

• Work alongside R&D, clinical, manufacturing, quality assurance, and legal teams to ensure alignment on regulatory requirements throughout the development process, ensuring regulatory compliance from discovery through commercialization.

• Manage interactions with regulatory authorities, including coordinating pre-IND meetings, advisory board discussions, and other regulatory interactions to ensure successful approvals and clearances.

• Proactively identify regulatory risks and gaps in product development plans, recommending and implementing strategies to mitigate risks and ensure regulatory milestones are met on time.

• Provide regulatory guidance on clinical trial designs, ensuring compliance with regulatory requirements while addressing feedback from regulatory agencies to streamline trial progress and approval.

• Oversee regulatory compliance for key markets, including North America, Europe, and Asia-Pacific, ensuring that the regulatory approach aligns with regional requirements and accelerates product approval pathways.

• Review and approve regulatory documents such as clinical trial applications, study reports, and submission materials, ensuring accuracy, consistency, and compliance with regulatory standards.

• Mentor and provide leadership to junior regulatory affairs professionals, promoting a collaborative, high-performance team culture focused on regulatory excellence.

Qualifications:

• Education:

  • A Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline is required. A Master’s degree or Ph.D. is a plus.

• Experience:

  • At least 7-10 years of experience in regulatory affairs within the biopharmaceutical or biologics industry, with specific expertise in cell and gene therapies or other advanced therapeutics.
  • Deep understanding of regulatory frameworks, guidelines, and requirements for cell and gene therapies (e.g., FDA, EMA, ICH, and global health authorities).
  • Proven track record in leading successful regulatory submissions, including INDs, BLAs, and MAAs for cell-based and/or gene therapies.
  • Experience in navigating regulatory interactions and meetings with global health authorities (FDA, EMA, etc.).
  • Familiarity with biologics development, from product characterization to clinical development and manufacturing.