Head of Regulatory Affairs
With a science-driven environment, and solid immuno-oncology data to support successful oncology endpoints, my client is primed to be one of the major players on the oncology marketplace. They are seeking a Head of Regulatory Affairs to play an integral part of the registration and maintenance of the company’s pipeline across the U.S. and world-wide. The ideal professional is someone who has the experience overseeing regulatory developments while hiring & managing a team in support of novel immune-oncology programs.
Responsibilities:
- Provide strategic regulatory input to the business
- Represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
- Ensure compliance with existing regulatory applications (e.g., IND maintenance including submission of Safety Reports, investigator documentation and Annual Reports)
- Participate in team meetings to assure cross-functional coordination
- Assist with the research, writing and implementation of effective regulatory strategies for global product development, and effectively communicate options, solutions and risks to development team
- Managed labeling changes, safety updates, artwork development and artwork approval of packaging material components
- Build effective working relationships with the regulatory agency and follow-up closely on approvals of product registration and variations
Knowledge and Skills:
- Minimum BA/BS, preferably in a scientific discipline
- Minimum of 12-15 years’ industry experience with 10 years spent in regulatory affairs
- Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA)
- Knowledge and understanding of applicable global regulations, guidance documents and regulatory pathways
- Knowledge of eCTD content/format requirements
- Ability to work both independently with direction and within project teams
- Excellent verbal and written communication skills are essential
- Strong organizational skills, including the ability to prioritize workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff