Director, Regulatory Affairs - Development Strategy
Insmed Incorporated
19 days ago
Remote
United States
Corporate Functions
Director, Regulatory Affairs – Development Strategy
Responsibilities / What You’ll Do
- Provide strategic and operational regulatory leadership to support business development and early-stage drug development programs.
- Lead regulatory due diligence for external assets, evaluating regulatory pathways, data packages, risks, and mitigation strategies.
- Critically assess nonclinical, clinical, and CMC data packages; identify gaps, risks, and value inflection points.
- Develop and execute global regulatory strategies for internal pipeline programs; serve as global/regional regulatory lead.
- Provide regulatory input to cross-functional project teams throughout product development and submission activities.
- Contribute to preparation and submission of regulatory documents (e.g., pre-IND meeting requests, briefing books, INDs, amendments).
- Support health authority interactions (meeting strategy, briefing materials, response development).
- Provide regulatory input into study design, endpoints, and development plans; ensure alignment across clinical, nonclinical, and CMC.
- Monitor the evolving regulatory landscape; proactively identify regulatory risks and propose mitigation strategies.
Qualifications
- Bachelor’s degree.
- 5+ years in Regulatory Affairs (or related), including hands-on regulatory submissions across multiple regions (U.S., EU and/or other markets).
- Early-stage drug development experience (pre-IND through Phase 2).
- Experience with regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings).
- Strong understanding of global regulatory frameworks and the drug development process.
- Ability to critically assess scientific/clinical/CMC data in a regulatory context.
Nice to Have
- Advanced degree (PhD, PharmD, MD, MS).
- Experience in regulatory due diligence, business development, or asset evaluation.
- Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus).
Application Instructions
- Not specified in the job description text provided.
Responsibilities / What You’ll Do
- Provide strategic and operational regulatory leadership to support business development and early-stage drug development programs.
- Lead regulatory due diligence for external assets, evaluating regulatory pathways, data packages, risks, and mitigation strategies.
- Critically assess nonclinical, clinical, and CMC data packages; identify gaps, risks, and value inflection points.
- Develop and execute global regulatory strategies for internal pipeline programs; serve as global/regional regulatory lead.
- Provide regulatory input to cross-functional project teams throughout product development and submission activities.
- Contribute to preparation and submission of regulatory documents (e.g., pre-IND meeting requests, briefing books, INDs, amendments).
- Support health authority interactions (meeting strategy, briefing materials, response development).
- Provide regulatory input into study design, endpoints, and development plans; ensure alignment across clinical, nonclinical, and CMC.
- Monitor the evolving regulatory landscape; proactively identify regulatory risks and propose mitigation strategies.
Qualifications
- Bachelor’s degree.
- 5+ years in Regulatory Affairs (or related), including hands-on regulatory submissions across multiple regions (U.S., EU and/or other markets).
- Early-stage drug development experience (pre-IND through Phase 2).
- Experience with regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings).
- Strong understanding of global regulatory frameworks and the drug development process.
- Ability to critically assess scientific/clinical/CMC data in a regulatory context.
Nice to Have
- Advanced degree (PhD, PharmD, MD, MS).
- Experience in regulatory due diligence, business development, or asset evaluation.
- Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus).
Application Instructions
- Not specified in the job description text provided.