Director, Global Regulatory Lead (GRL)

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. 

Summary:

The Director, Global Regulatory Lead (GRL) is accountable for developing and executing innovative, integrated global regulatory strategies for assigned assets from development through approval and lifecycle management. Serving as the primary regulatory strategic partner to cross-functional development and governance teams, the Director translates scientific, clinical, safety, CMC, labeling, operational, and business priorities into clear regulatory plans and decisions. This role leads through a global matrix, aligns requirements across major health authorities—including the FDA, EMA, PMDA, ANVISA, and CDE)—anticipates and mitigates complex regulatory risks, and represents the company with regulatory authorities, contractors, and corporate partners. The Director independently drives key regulatory decisions and escalates material issues and recommendations to senior leadership and governance bodies as appropriate.

Roles and Responsibilities:

• Own and direct integrated global regulatory strategies for assigned assets, indications, and development programs.
• Serve as the Global Regulatory Lead and senior regulatory advisor to cross-functional development, product, and governance teams.
• Lead regulatory strategy across preclinical and clinical development, registration, approval, and global lifecycle management as relevant for assigned programs.
• Integrate US, EU, Japan, China, Brazil and other regional requirements into a cohesive global strategy in partnership with regional and local regulatory colleagues.
• Set strategic direction for regulatory submission planning and execution, including clinical trial applications, briefing packages, major marketing applications, amendments, supplements, and health authority responses.
• Plan and lead health authority interactions, articulate the company position, and negotiate complex scientific and regulatory matters.
• Identify and assess regulatory risks, opportunities, emerging requirements, and policy developments; recommend mitigation strategies and changes to program plans.
• Provide strategic regulatory input to development plans, protocols, data requirements, CMC strategy, safety strategy, labeling, and commercialization planning.
• Communicate regulatory strategy, priorities, trade-offs, and recommendations to senior R&D, Commercial, Business, and governance leaders.
• Represent Global Regulatory Affairs on cross-functional teams and with health authorities, contractors, corporate partners, industry groups, and external committees.
• Influence portfolio and program decisions by integrating regulatory, scientific, operational, and business considerations.
• Contribute to functional strategy, resource prioritization, continuous improvement, and a collaborative, accountable culture.

Qualifications

Required Experience: Prior experience as a regional or global regulatory lead, ideally with direct responsibility for US and/or EU strategy.

• Degree in life sciences, pharmacy, medicine, or a related discipline required; an advanced degree such as PharmD, MSc, PhD, or MBA is preferred.
• Typically 10 or more years of progressive pharmaceutical or biotechnology industry experience, including at least 7 years in Regulatory Affairs strategy.
• Demonstrated experience developing and executing global or international regulatory strategy across more than one major region.
• Significant experience supporting products in development, including clinical and preclinical regulatory strategy.
• Late-stage development experience, including leadership of a major regulatory submission such as an NDA, BLA, or MAA.
• Direct experience leading interactions with major regulatory authorities, including the FDA, EMA, and PMDA.
• Strong knowledge of global regulations, guidance, policy, and the preparation of major submissions, amendments, and supplements.

• Demonstrated strategic judgment and the ability to make decisions with significant program, submission, timeline, labeling, supply, or business impact.
• Proven ability to lead and influence senior cross-functional teams, governance bodies, health authorities, and corporate partners without direct authority.
• Excellent leadership, negotiation, analytical, presentation, written, and verbal communication skills.
• Ability to translate complex regulatory issues into clear options, recommendations, and actionable plans for senior leaders.
• Strong organizational skills and the ability to prioritize across multiple programs, deliverables, and competing business needs.
• Strong interpersonal skills and the ability to build trusted relationships with senior medical, scientific, safety, quality, manufacturing, and commercial stakeholders.
• Ability to work effectively in a multicultural, multinational environment and lead multidisciplinary global teams.

Work Arrangement:

Hybrid

Travel Requirements:

10% travel
‎

Education:

PharmD 

Benefits and Perks:

Apellis offers a comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave and more!

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

 

For more information, please visit http://apellis.com or follow us on LinkedIn and X.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.