21 days ago
- Develops clinical and diagnostic regulatory strategies
- Coordinates, writes, compiles, as appropriate, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications.
- Oversee the establishment, maintenance, and successful implementation of Regulatory & Quality processes and procedures
- Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
- Ensure all interactions with Agency personnel (US/Ex-US) are conducted to the highest degree of professionalism.
- Manage key relationships and strategic discussion with large pharmaceutical partners, ensuring program advancement, quality discussions, and desirable outcomes.
- Minimum 10 years combined experience in Regulatory Affairs, Experience in Quality Assurance preferred but not required.
- Minimum 5 years of experience in regulatory oncology in a leadership capacity.
- Excellent working knowledge of US and EU regulations and guidelines.
- Successful regulatory filings associated with full life-cycle development: IND/NDA/MAA CTA, amendments
- Minimum of a bachelor’s degree in a life science required. MS or PhD degree is preferred.