Senior Director, Regulatory CMC

Role Overview

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.

• Regulatory Strategy & Leadership:
  • 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.
• Submission Management:
  • 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.
• Health Authority Interactions:
  • 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.
• Team Leadership &
  
  Collaboration:
  • 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.
• Compliance & Intelligence:
  • 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.

• 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.
• 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.
• 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.
• Strong external network with regulatory agencies or participation in industry working groups preferred.
• Experience leading teams and developing talent preferred.
• Excellent organizational, analytical, and strategic thinking skills.

• This role is remote and is based in the US.
• Preference for candidates in the Northeastern US as travel to the corporate office outside of Philadelphia, PA and global vendor/partner sites is required.

• 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

Savara’s compensation for this role will include a base salary, bonus, and equity. The base salary range for this role is $230,000 to $260,000.

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.