My client is using an unconventional approach to develop cancer immunotherapies and bring long-lasting benefits to patients. They are looking for a Regulatory Affairs Senior Manager to manage all aspects of regulatory affairs for their clinical development programs. You will be the right hand to the Vice President of Regulatory, managing all submissions and working closely with health authorities. This is a growing public company with an energetic science-driven culture, where you can help to get life-saving programs approved and make an immediate impact.
Responsibilities:
- Assist the Vice President of Regulatory Affairs in developing global regulatory strategies for multiple pipeline programs.
- Represent Regulatory Affairs on cross-functional project teams, providing regulatory guidance and education through the interpretation of regulations, policies, guidelines, and compliance requirements.
- Maintain and update regulatory strategy documents and target product profiles for assigned programs.
- Compile, review, submit, and maintain all clinical trial applications and marketing authorizations.
- Interact directly with health authorities, compile briefing books and prepare for FDA meetings.
- Stay abreast of regulatory intelligence and communicate relevant trends to senior management.
Knowledge and Skills:
- Bachelor’s degree in a scientific or health-related field; Advanced degree highly preferred.
- Minimum seven years of Regulatory Affairs experience in the biopharmaceutical industry.
- Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for biologic programs.
- Must have regulatory experience with oncology or immune-oncology programs.
- In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development.
- Experience preparing, reviewing and filing INDs/CTAs and/or NDA/BLA/MAAs.
- Track record of building an excellent relationship with the FDA and other regulatory agencies.
- Experience with development of biomarkers and IVD companion diagnostics devices a plus.
- Strategic thinker with excellent problem solving and influencing skills.
- Exceptional writing, communication and presentation skills.