Hemab Therapeutics · 1 week ago
Director of Regulatory Affairs, CMC
Cambridge, MA
Full-time
Onsite
Director/Executive
8+ years expHemab Therapeutics is seeking a Director of Regulatory Affairs, CMC to lead global regulatory strategy across their portfolio of rare disease therapies. This role provides strategic leadership for all CMC-related regulatory activities, ensuring high-quality submissions and successful interactions with global health authorities.
BiotechnologyLife ScienceMedicalPharmaceutical
Responsibilities
Lead the development and execution of global CMC regulatory strategies for biologic products, including gene therapies, ensuring alignment with overall product development objectives and regulatory timelines
Serve as the CMC regulatory representative on cross-functional project teams, providing strategic input and guidance on CMC development activities to support regulatory submissions
Author and/or review CMC sections of regulatory submissions including INDs, CTAs, BLAs/MAAs, and amendments, ensuring high-quality documentation that meets global regulatory requirements
Collaborate closely with CMC technical teams (Process Development, Analytical Development, Manufacturing, Quality) to ensure regulatory strategies are integrated into development plans and executed effectively
Lead CMC regulatory aspects of health authority interactions, including preparation of briefing documents, responses to agency questions, and participation in regulatory meetings (Type B, Type C, Scientific Advice)
Proactively identify CMC regulatory risks and develop mitigation strategies, communicating potential impacts to project teams and senior management in a timely manner
Provide regulatory assessment and strategic guidance for CMC changes throughout the product lifecycle, including manufacturing process improvements, analytical method changes, and facility transfers
Oversee CMC regulatory activities conducted by external vendors and consultants, ensuring deliverables meet quality standards and timelines
Monitor evolving global CMC regulatory landscape, guidelines, and precedents to inform strategic decisions and maintain compliance across all programs
Partner with Quality Assurance to ensure CMC activities align with GMP requirements and support regulatory inspections readiness
Mentor and develop junior regulatory staff in CMC regulatory affairs expertise
Travel may be required (up to 10% of the time)
Qualification
Required
Bachelor's degree in life sciences, chemistry, engineering, or related scientific discipline required
8+ years of pharmaceutical/biotechnology industry experience with at least 5 years in regulatory affairs with significant CMC focus, or equivalent combination of technical CMC and regulatory experience
Demonstrated experience with biologics CMC regulatory submissions (INDs, BLAs) and successful health authority interactions
Track record of developing successful CMC regulatory strategies for complex biologics and/or peptides through various stages of development
Experience with preparing global regulatory submissions to FDA and EMA as well as ex-US/EU regulatory Agencies (e.g., PMDA, Health Canada)
Deep understanding of global CMC regulatory requirements and guidance documents for biologics, including ICH guidelines (Q5, Q6, Q8-Q11)
Strong scientific acumen with ability to understand and communicate complex technical CMC information to regulatory agencies and internal stakeholders
Demonstrated ability to think strategically while managing tactical execution of CMC regulatory deliverables
Excellent written and verbal communication skills with proven ability to author high-quality regulatory documents and present to senior management
Strong project management skills with ability to manage multiple priorities and meet aggressive timelines in a fast-paced environment
Collaborative leadership style with ability to influence without direct authority and work effectively across functional boundaries
Problem-solving mindset with ability to develop creative solutions to complex CMC regulatory challenges
Detail-oriented with strong organizational skills and commitment to quality
Proficiency with regulatory information management systems and electronic submission formats
Preferred
Advanced degree (MS, PhD, PharmD)
Familiarity with submission requirements for Regulatory Agencies in Middle East, Latin America and Asia
Company
Hemab Therapeutics
Hemab is a clinical-stage biotech company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$347MKey Investors
Sofinnova PartnersAccess BiotechnologyNovo Holdings
2025-10-27Series C· $157M
2023-02-21Series B· $135M
2021-07-22Series A· $55M
Leadership Team
Benny Sørensen
Chief Executive Officer
Mads Behrndt
Chief Financial Officer
Recent News
2025-11-19
Company data provided by crunchbase