15 days ago
- Work with Regulatory Affairs team to establish development and regulatory strategies for early-stage and late-stage development programs.
- Collaborate with cross functional teams such as CMC, clinical, labeling, and post-approval, representing and coordinating regulatory information.
- Liaise with EU, Canadian, and US Health Authorities.
- Prepare IND, NDA, CTA and BLA submissions including original marketing applications, amendments, supplements, variations, responses to Health Authority questions and requests, briefing packages, annual reports, periodic safety reports, etc.
- Participate in the electronic review and quality verification of regulatory submissions.
- Ensure adherence to regulations and applicable guidelines for all regulatory submissions.
- Provide risk assessments and recommendations for various regulatory scenarios.
- Bachelor's degree required; Advanced degree preferred.
- Minimum of 4 years of regulatory strategy experience within the pharmaceutical or biotechnology environment.
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages.
- Excellent verbal and written communication skills.
- Ability to work with limited supervision, to set priorities to meet timelines.
- Occasional travel required.