We are seeking a Global Regulatory Lead to develop global regulatory strategies for clinical development programs and to lead interactions with major health authorities. This client is a successful global biotechnology company which is developing medicines for the treatment of debilitating neurological and neurodegenerative diseases. With ten approved products and a strong clinical pipeline, this is a great place to advance your career while helping to improve patients’ lives.
- Developing and directing global regulatory strategies for assigned projects and programs.
- Support development of late stage clinical development plans.
- Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
- Provide regulatory guidance to company personnel throughout the research and development process.
- Advise on global CTA submission strategy.
- Mentor Regulatory Strategists and guide direct reports in carrying out responsibilities.
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
Knowledge and Skills:
- Bachelor degree in a scientific field is required. Advanced degree preferred.
- Eight or more years of pharmaceutical/biotechnology industry experience with at least six years in Regulatory Affairs for clinical and pre-clinical programs.
- Comprehensive knowledge of US and Global regulations and experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, etc) and supportive amendments or supplements.
- Ability to foster effective, positive interactions with regulatory agencies and corporate partners.
- Ability to lead and influence project teams and committees to attain group goals.
- Excellent leadership and communication skills.
- Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Prior supervisory/mentoring experience.