Key skills
Leadership
About this role
Role Overview
- Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
- Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
- Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
- Identify, communicate, and escalate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership.
- Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide.
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- 10 years relevant experience including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s degree, or Master’s degree; minimum 5 years for candidates with a Ph.D. degree
- demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance).
- subject matter expertise in combination product regulatory development and manufacturing
- experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products
- strong knowledge and understanding of design controls process
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days