Global Regulatory Lead, Immunology Expansion, WCH
Biogen
5 months ago
On-site
San Francisco, CA
Corporate Functions
Responsibilities:
- Serve as Global Regulatory Lead (GRL) for early and late-stage West Coast Hub (WCH) programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion).
- Own and continuously evolve the global regulatory strategy as programs advance, increase in complexity, and expand across indications and geographies.
- Provide WCH portfolio-level regulatory leadership (development sequencing, indication prioritization, and long-term regulatory positioning).
- Recommend expansion, modification, or curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
- Provide scientific and regulatory guidance and serve as a recognized technical expert/thought leader.
- Lead complex cross-functional regulatory workstreams (Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external partners).
- Lead and negotiate high-impact interactions with global health authorities (e.g., FDA, EMA, PMDA) including milestone/advisory engagements and alignment on development/registration plans.
- Make decisions impacting departmental and enterprise objectives, results, reputation, and regulatory risk; contribute to portfolio planning and go/no-go decisions.
- Mentor and lead regulatory team members; support scaling/maturation of the Regulatory function and establish best-in-class regulatory frameworks.
Qualifications & Experience:
- Bachelor’s degree; advanced degree (PhD, PharmD, MS, MD, or related life-science discipline) preferred.
- 15+ years of progressive Regulatory Affairs experience in the biopharmaceutical industry.
Required Skills:
- Demonstrated success as a Global Regulatory Lead on late-stage programs, including major submissions (NDA, BLA, MAA).
- Proven experience owning global regulatory strategy across early- to late-stage development, including lifecycle management and indication expansion.
- Deep understanding of global clinical, registration, and post-approval regulatory requirements.
- Strong record of strategic influence, executive-level communication, and cross-functional leadership.
- Ability to translate complex scientific/regulatory topics into clear business strategies and decision frameworks.
- Thrives in fast-paced, high-growth environments with enterprise-level thinking and hands-on leadership.
Benefits:
- Medical, Dental, Vision & Life insurance; Fitness & Wellness (fitness reimbursement); Short- and Long-Term Disability; Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); Up to 12 paid holidays + 3 personal days; Sick time (80 hours/year); Paid Maternity and Parental Leave; 401(k) with company match; Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
- Serve as Global Regulatory Lead (GRL) for early and late-stage West Coast Hub (WCH) programs; own global regulatory strategy across the full product lifecycle (early development through registration, post-approval, and indication expansion).
- Own and continuously evolve the global regulatory strategy as programs advance, increase in complexity, and expand across indications and geographies.
- Provide WCH portfolio-level regulatory leadership (development sequencing, indication prioritization, and long-term regulatory positioning).
- Recommend expansion, modification, or curtailment of development strategies based on scientific evidence, regulatory intelligence, and evolving health authority expectations.
- Provide scientific and regulatory guidance and serve as a recognized technical expert/thought leader.
- Lead complex cross-functional regulatory workstreams (Clinical Development, PO&T, Clinical Operations, Pharmacovigilance, Medical Affairs, Commercial, and external partners).
- Lead and negotiate high-impact interactions with global health authorities (e.g., FDA, EMA, PMDA) including milestone/advisory engagements and alignment on development/registration plans.
- Make decisions impacting departmental and enterprise objectives, results, reputation, and regulatory risk; contribute to portfolio planning and go/no-go decisions.
- Mentor and lead regulatory team members; support scaling/maturation of the Regulatory function and establish best-in-class regulatory frameworks.
Qualifications & Experience:
- Bachelor’s degree; advanced degree (PhD, PharmD, MS, MD, or related life-science discipline) preferred.
- 15+ years of progressive Regulatory Affairs experience in the biopharmaceutical industry.
Required Skills:
- Demonstrated success as a Global Regulatory Lead on late-stage programs, including major submissions (NDA, BLA, MAA).
- Proven experience owning global regulatory strategy across early- to late-stage development, including lifecycle management and indication expansion.
- Deep understanding of global clinical, registration, and post-approval regulatory requirements.
- Strong record of strategic influence, executive-level communication, and cross-functional leadership.
- Ability to translate complex scientific/regulatory topics into clear business strategies and decision frameworks.
- Thrives in fast-paced, high-growth environments with enterprise-level thinking and hands-on leadership.
Benefits:
- Medical, Dental, Vision & Life insurance; Fitness & Wellness (fitness reimbursement); Short- and Long-Term Disability; Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); Up to 12 paid holidays + 3 personal days; Sick time (80 hours/year); Paid Maternity and Parental Leave; 401(k) with company match; Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.