Director, Regulatory Affairs

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

The Director, Regulatory Affairs will be responsible for the strategic leadership, development and execution of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under his/her accountability. This role serves as a key regulatory leader and decision maker, influencing program direction and regulatory positioning across regions.

Key Responsibilities

• Ensure alignment of global regulatory strategies with Apellis corporate objectives. Lead and influence cross-functional discussions to ensure the global regulatory strategy is incorporated and implemented within the stakeholder deliverables throughout development and commercialization.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to serve as the primary regulatory strategic advisor, strategically interpret, plan, and communicate requirements to strategy teams. Communicate to regulatory team, cross-functional teams, and senior leaders clear regulatory risks, options, trade-offs, and immediate to long-range plans to carry out established objectives.
• Provide global regulatory leadership and strategic perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s), including clinical protocols, annual reports, clinical trial applications (CTA) / IND amendments, marketing applications, and post-approval change documents.
• Lead the development of global regulatory strategy plans and the content of global regulatory dossiers. Oversee and be accountable for regulatory agency submissions and approvals, with a quality focus to secure first-cycle approvals. Ensure compliance with global regulatory requirements. Drive resolution of regional conflicts in global regulatory strategies and oversee critical deliverables to all territories.
• Represent the company as the regulatory lead at key regulatory agency meetings; lead, moderate, and negotiate discussions with health authorities.
• Develop and maintain trusted productive relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes and proactively shape regulatory pathways.
• Proactively anticipate, assess, and mitigate regulatory risks. Demonstrate critical thinking, leadership, and project management accountability in close collaboration with strategy teams. Under minimal guidance of supervisor, provide clear, actionable regulatory assessments and recommendations to teams and senior leadership.
• Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Assess the impact of evolving global regulatory landscapes on assigned programs and provide relevant guidance and expertise to project/program teams.
• Demonstrate strong understanding of US FDA, EU EMA, and international guidance, regulations, drug development process, and leadership behaviors consistent with a Director level role including strategic thinking, cross-functional influence, and mentorship as appropriate.
• May provide functional or matrix leadership, mentorship, and regulatory oversight to other Regulatory Affairs team members or project team members.

B.S. or graduate degree in life sciences

Regulatory Affairs Certification preferred

• At least 10 years of progressive regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience), with US and international regulatory experience.
• Demonstrated experience leading global regulatory strategies and major health authority interactions required.
• Ophthalmology experience preferred.

Travel Requirements:
None

Bachelor's Degree

Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $196,000-$294,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.

Benefits and Perks:
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more. This information is available at

Company Background:
Apellis Pharmaceuticals, Inc. is a…