Apellis Pharmaceuticals · 1 day ago
Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$196K/yr - $294K/yr
10+ years expApellis Pharmaceuticals 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. The Director, Regulatory Affairs will be responsible for the strategic leadership, development, and execution of globally aligned regulatory strategies, serving as a key regulatory leader and decision maker across regions.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
B.S. or graduate degree in life sciences
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
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
Preferred
Regulatory Affairs Certification preferred
Ophthalmology experience preferred
Benefits
401(k) plan with company match
Inclusive family building benefits
Flexible time off
Summer and winter shutdowns
Paid family leave
Disability and life insurance
More!
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (6)
2023 (6)
2022 (8)
2021 (7)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$919.6MKey Investors
Swedish Orphan BiovitrumSixth StreetNorthern Star Partners
2025-06-01Post Ipo Debt· $275M
2024-05-14Post Ipo Debt· $475M
2022-04-14Post Ipo Equity· $1.07M
Leadership Team
Cedric Francois
Co-Founder and CEO
Caroline Baumal
Chief Medical Officer
Recent News
2026-01-18
Investor's Business Daily
2026-01-13
Company data provided by crunchbase