What are the responsibilities and job description for the Director/Associate Director, Regulatory Affairs position at BioTalent?
Director / Associate Director, Regulatory AffairsJob DescriptionThis 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).#J-18808-Ljbffr
