Senior Director, Regulatory CMC
About The Position
The Senior Director, Regulatory-CMC will lead global regulatory strategy and CMC development for Savara’s clinical and commercial programs. This role will be responsible for shaping and executing regulatory CMC strategies that enable the advancement of innovative products from development through commercialization. The ideal candidate is a strategic regulatory professional with deep technical expertise, outstanding leadership skills, and a proven record of successful global submissions. This role is classified as hybrid/remote, with a strong preference for candidates in the Northeastern US.
Requirements
- Advanced degree (Ph.D., Pharm.D., M.S., or equivalent) in chemistry, engineering, pharmaceutical sciences, or related discipline required.
- Minimum 12–15 years of experience in Regulatory Affairs, with significant CMC leadership experience in the biotech/pharmaceutical industry required.
- Proven track record of successful global submissions (IND, NDA, BLA, MAA or equivalents) required.
- Strong knowledge of cGMP, ICH, and regional regulatory guidelines for CMC activities.
- Demonstrated ability to influence and communicate effectively with senior executives, health authorities, and cross-functional partners.
- Excellent organizational, analytical, and strategic thinking skills.
Nice To Haves
- Experience with biologics, cell/gene therapy or complex modalities preferred.
- Prior experience with pre-approval of CMC strategy development and post-approval CMC lifecycle management preferred.
- Strong external network with regulatory agencies or participation in industry working groups preferred.
- Experience leading teams and developing talent preferred.
Responsibilities
- Develop and lead comprehensive global Regulatory CMC strategies for investigational and commercial products, ensuring alignment with corporate objectives.
- Serve as the primary CMC regulatory expert for cross-functional teams, providing strategic input on product development, manufacturing, and lifecycle management.
- Represent Regulatory Affairs in cross-functional project teams and governance committees.
- Oversee the preparation and submission of high-quality regulatory CMC dossiers, including IND/IMPD, NDA/BLA/MAA, supplements, and lifecycle management submissions.
- Ensure timely responses to health authority questions and requests related to CMC topics.
- Provide strategic guidance on CMC documentation to ensure consistency, scientific rigor, and regulatory compliance.
- Lead or support CMC-related meetings and communications with global health authorities (e.g., FDA, EMA, MHRA, PMDA).
- Proactively anticipate regulatory challenges and propose effective solutions.
- Potentially manage and mentor a small team of Regulatory CMC professionals as the organization grows and evolves.
- Partner closely with Technical Operations, Quality, Analytical, and Process Development teams to align CMC strategies with regulatory expectations.
- Foster a culture of excellence, accountability, and regulatory innovation.
- Maintain awareness of evolving global CMC regulations, guidance documents, and industry trends.
- Translate regulatory changes into actionable strategies for the organization.
- Other duties as assigned.
Benefits
- Highly competitive medical, dental, and vision coverage
- Flexible Spending Account for health care and dependent care expenses and Health Savings Account
- Paid time off and paid holidays, including Dec 24-Jan 1
- Paid parental leave
- 401(k) with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
