Director/Associate Director, Regulatory Affairs

Job Description
This position offers an exciting opportunity in a fast-paced and innovative biopharmaceutical environment. The role involves developing and implementing global regulatory strategies across clinical, non-clinical, and CMC disciplines. The successful candidate will ensure the timely preparation of scientifically valid regulatory submissions and provide strategic input to cross-functional project teams. This role may also involve mentoring and potentially supervising regulatory professionals and requires strategic thinking and the ability to collaborate effectively in a global team environment.

Key Responsibilities:

• Provide strategic and operational regulatory input across clinical, non-clinical, and CMC areas in collaboration with cross-functional teams.
• Develop global clinical regulatory plans and strategies, propose risk mitigation approaches, and influence project teams across international locations.
• Offer regulatory guidance throughout the product lifecycle, from development to commercialization, ensuring compliance and identifying opportunities for product expansion.
• Represent the company in interactions with regulatory authorities.
• Prepare and manage technically complex submissions requiring extensive coordination across departments.
• Maintain expertise in regulatory requirements and communicate updates to project teams.
• Contribute to internal regulatory policies and procedures to align with best practices and ensure efficient workflows.
• Schedule and oversee activities related to regulatory deliverables, both individually and for direct reports, as applicable.

Requirements:

• Bachelor’s degree in a scientific discipline is required; an advanced degree is strongly preferred.
• A minimum of 8 years of regulatory experience, including investigational and marketed products.
• Proven ability to lead cross-functional teams in preparing regulatory submissions.
• Experience working on international teams and submissions is desirable.
• Comprehensive knowledge of regulatory requirements, including ICH and regional standards, with the ability to assess their impact on business operations.
• Strong skills in critically reviewing technical documents and influencing cross-functional teams.
• Experience with regulatory dossiers (e.g., CTAs, IMPDs, INDs) is required; marketing application experience is a plus.
• Familiarity with drug-device combination products is preferred.
• Ability to travel domestically and internationally (10–20% of the time).