Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory strategy across our portfolio of rare disease therapies. This role provides strategic leadership for all CMC-related regulatory activities—from early development through commercialization—ensuring high-quality submissions and successful interactions with global health authorities.
The Director will work cross-functionally across CMC, Quality, Clinical, and Program Leadership teams and will play a critical role in shaping Hemab’s global development and registration strategies. This role requires deep expertise in biologics CMC regulatory requirements and the ability to navigate complex regulatory landscapes while advancing innovative manufacturing and analytical.
Key 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).
QUALIFICATIONS AND EXPERIENCE
- Bachelor's degree in life sciences, chemistry, engineering, or related scientific discipline required. Advanced degree (MS, PhD, PharmD) preferred.
- 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). Familiarity with submission requirements for Regulatory Agencies in Middle East, Latin America and Asia is highly desirable.
SKILLS & ABILITIES
- 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.
WHO YOU ARE
- We are looking for a person who combines strategic leadership with a willingness to roll up their sleeves.
- A strategic thinker who can anticipate regulatory challenges and design clear pathways forward.
- Someone who can execute hands-on, diving into details and supporting the team where needed.
- A strong communicator who can craft compelling regulatory storylines while also authoring high-quality content.
- Collaborative, proactive, and comfortable working in a dynamic, fast-paced biotech environment.
