Senior Director, Regulatory CMC

Position Summary:

The Senior Director Regulatory CMC will lead and evolve Apelliss global Chemistry Manufacturing and Controls (CMC) strategies to support the companys innovative therapeutic pipeline and marketed products. This position is responsible for developing executing and maintaining high-impact CMC regulatory strategies across development and commercial stages ensuring global compliance while driving innovation and operational efficiency. The role will oversee both Regulatory CMC and Regulatory Device functions serving as a key cross-functional leader who leverages data-driven systems AI-enabled document management and digital regulatory tools to enhance submission quality accelerate timelines and ensure inspection readiness.

The successful candidate will be a strategic hands-on leader who fosters collaboration across Technical Operations Quality Manufacturing Device Engineering Research & Development and Project Management. They will bring a strong blend of technical acumen regulatory insight and interpersonal effectiveness to build trust align priorities and drive results in a matrixed global organization. The Senior Director must demonstrate exceptional leadership presence the ability to influence at all levels and a commitment to developing and empowering high-performing teams.

Preferred job location: Waltham MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

Leadership and Strategy

• Lead global CMC and device regulatory strategies from development through commercialization ensuring alignment with business goals and global regulatory expectations.
• Create and implement a long-term CMC regulatory plan that aligns with Apelliss product pipeline strategy supporting both short-term milestones and long-range business objectives.
• Partner with Technical Operations Quality and Device Engineering to define robust CMC strategies supporting INDs CTAs NDAs/BLAs MAAs and lifecycle management submissions.
• Oversee regulatory risk assessments and proactively identify and mitigate potential CMC or device-related regulatory hurdles.
• Champion innovation in regulatory processes integrating digital transformation initiatives and AI-based systems for predictive compliance and submission optimization.
• Provide line management and leadership to direct reports including employees and contractors ensuring clarity of roles accountability and opportunities for professional development.
• Oversee budget planning and resource allocation for Regulatory CMC and Device functions ensuring alignment with organizational priorities and efficient use of resources.

Regulatory Execution

• Direct and oversee the preparation review and submission of high-quality global CMC and device-related regulatory filings (INDs IMPDs CTAs NDAs/BLAs MAAs variations supplements and responses to health authority inquiries).
• Ensure consistency scientific integrity and accuracy across all submissions through effective governance and collaboration with cross-functional contributors.
• Lead regulatory CMC interactions and negotiations with FDA EMA and other global agencies effectively representing Apellis in technical and strategic discussions.
• Manage post-approval changes globally in accordance with emerging regulatory frameworks ensuring timely compliance and lifecycle management.

Operational Excellence

• Build and mentor a high-performing team of Regulatory CMC and Device professionals fostering an inclusive agile and innovative culture.
• Develop and maintain regulatory processes and tools leveraging AI-assisted content management structured data submissions (e.g. eCTD IDMP PQ/CMC) and next-generation regulatory intelligence platforms.
• Collaborate with Regulatory Operations IT and Quality teams to integrate digital solutions for regulatory document tracking real-time submission status visualization and compliance analytics.
• Establish and maintain KPIs and dashboards to monitor submission performance regulatory commitments and agency interactions.

Cross-functional Collaboration

• Serve as the senior regulatory liaison for CMC and device topics within global project teams and governance committees.
• Partner with internal stakeholders to ensure regulatory considerations are embedded in product development manufacturing strategy and change control.
• Support due diligence licensing and partnership activities by providing expert regulatory CMC and device assessments.

Education Registration & Certification:

• Advanced degree (Ph.D. Pharm.D. M.S.) in a relevant scientific discipline (e.g. Chemistry Biochemistry Pharmaceutical Sciences Chemical Engineering) preferred;
  Bachelors degree with exceptional experience will be considered.

Experience:

• Minimum of 15 years of experience in Regulatory Affairs within the biopharmaceutical industry including 8 years of direct CMC regulatory experience and 5 years in a leadership role.
• Proven track record of leading global CMC submissions and successful interactions with regulatory authorities (FDA EMA PMDA Health Canada etc.).

Skills Knowledge & Abilities:

Technical Expertise

• Deep understanding of global CMC and device regulatory frameworks including ICH guidelines FDA/EMA CMC requirements and post-approval change management.
• Strong grasp of analytical methods process development validation and manufacturing principles relevant to biologics and small molecules.
• Familiarity with regulatory technology systems such as Veeva Vault RIM IDMP data governance and structured content authoring tools.

Leadership and Communication

• Exceptional leadership and people development skills; ability to manage mentor coach and build high-performing global teams.
• Strong communication and negotiation skills with a proven ability to represent the company effectively to global health authorities.
• Strategic and analytical mindset with the ability to balance innovation risk and compliance.

Innovation and Digital Agility

• Demonstrated experience applying AI machine learning or automation tools to regulatory processes (e.g. submission readiness document QC regulatory intelligence) is an advantage.
• Proficiency with core Microsoft Office tools data visualization tools and digital collaboration platforms.
• Adaptable and forward-thinking with a commitment to continuous improvement and operational excellence.

Physical Demands and Work Environment:

This is largely a sedentary role; however some filing is required. This would require the ability to lift files open filing cabinets and bend or stand on a stool as job operates in a professional office environment and routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks:

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 $239000- $358000 per year. 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.

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! Visithttps:// to learn more.

Company Background:

Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion 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 approved medicines targeting C3. These include the first and only therapy for geographic atrophy a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information please visit follow us onTwitterandLinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees applicants or any other covered persons because of race color religion creed national origin or ancestry ethnicity sex (including pregnancy) gender (including gender nonconformity and status as a transgender or transsexual individual) age physical or mental disability citizenship past current or prospective service in the uniformed services genetic information marital status AIDS/HIV status smoker/nonsmoker and occupational pneumoconiosis or any other characteristic protected under applicable federal state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.

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.