Director, Global Regulatory Lead (GRL)
Apellis Pharmaceuticals
September 03, 2026
Remote friendly (United States)
United States
Corporate Functions
Roles and Responsibilities:
- Own and direct integrated global regulatory strategies for assigned assets, indications, and development programs.
- Serve as Global Regulatory Lead and senior regulatory advisor to cross-functional development, product, and governance teams.
- Lead regulatory strategy across preclinical/clinical development, registration, approval, and global lifecycle management.
- Integrate US, EU, Japan, China, Brazil, and other regional requirements into a cohesive global strategy.
- Set direction for regulatory submission planning and execution (clinical trial applications, briefing packages, major marketing applications, amendments, supplements, and health authority responses).
- Plan and lead health authority interactions; negotiate complex scientific and regulatory matters.
- Identify and assess regulatory risks, opportunities, emerging requirements, and policy developments; recommend mitigation and program changes.
- Provide strategic regulatory input to development plans, protocols, data requirements, CMC, safety, labeling, and commercialization planning.
- Communicate regulatory strategy, priorities, trade-offs, and recommendations to senior leaders.
- Represent Global Regulatory Affairs on cross-functional teams and with health authorities and external partners.
Qualifications:
Required:
- Prior experience as a regional/global regulatory lead (direct US and/or EU strategy preferred).
- Degree in life sciences/pharmacy/medicine or related (PharmD/MSc/PhD/MBA preferred).
- Typically 10+ years in pharma/biotech, including 7+ years in Regulatory Affairs strategy.
- Experience developing and executing global/international regulatory strategy across multiple major regions.
- Significant experience supporting products in development (clinical and preclinical).
- Late-stage experience leading major submissions (NDA/BLA/MAA).
- Direct experience with FDA/EMA/PMDA.
- Strong knowledge of global regulations, guidance, policy, and major submissions/amendments/supplements.
- Strategic judgment; ability to lead/influence senior cross-functional teams without direct authority.
- Excellent leadership, negotiation, analytical, and communication skills.
- Strong organizational and interpersonal skills.
Work Arrangement: Hybrid
Travel: 10%
Benefits: comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave, and more.
Education: PharmD
- Own and direct integrated global regulatory strategies for assigned assets, indications, and development programs.
- Serve as Global Regulatory Lead and senior regulatory advisor to cross-functional development, product, and governance teams.
- Lead regulatory strategy across preclinical/clinical development, registration, approval, and global lifecycle management.
- Integrate US, EU, Japan, China, Brazil, and other regional requirements into a cohesive global strategy.
- Set direction for regulatory submission planning and execution (clinical trial applications, briefing packages, major marketing applications, amendments, supplements, and health authority responses).
- Plan and lead health authority interactions; negotiate complex scientific and regulatory matters.
- Identify and assess regulatory risks, opportunities, emerging requirements, and policy developments; recommend mitigation and program changes.
- Provide strategic regulatory input to development plans, protocols, data requirements, CMC, safety, labeling, and commercialization planning.
- Communicate regulatory strategy, priorities, trade-offs, and recommendations to senior leaders.
- Represent Global Regulatory Affairs on cross-functional teams and with health authorities and external partners.
Qualifications:
Required:
- Prior experience as a regional/global regulatory lead (direct US and/or EU strategy preferred).
- Degree in life sciences/pharmacy/medicine or related (PharmD/MSc/PhD/MBA preferred).
- Typically 10+ years in pharma/biotech, including 7+ years in Regulatory Affairs strategy.
- Experience developing and executing global/international regulatory strategy across multiple major regions.
- Significant experience supporting products in development (clinical and preclinical).
- Late-stage experience leading major submissions (NDA/BLA/MAA).
- Direct experience with FDA/EMA/PMDA.
- Strong knowledge of global regulations, guidance, policy, and major submissions/amendments/supplements.
- Strategic judgment; ability to lead/influence senior cross-functional teams without direct authority.
- Excellent leadership, negotiation, analytical, and communication skills.
- Strong organizational and interpersonal skills.
Work Arrangement: Hybrid
Travel: 10%
Benefits: comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave, and more.
Education: PharmD