Director, Regulatory Affairs CMC

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne’s development programs, from early-stage development through commercialization and post-approval lifecycle management.

This individual will serve as a strategic leader and subject matter expert (SME), ensuring high-quality, compliant, and globally aligned CMC regulatory submissions. The role will partner closely with Manufacturing, Quality, Clinical Operations, and Program Teams to support clinical registration, commercial readiness, and ongoing regulatory compliance.

The position requires a highly experienced regulatory professional capable of operating independently, influencing cross-functional stakeholders, and driving complex regulatory strategies while meeting critical timelines in a fast-paced, dynamic biotech environment.

Primary Responsibilities Include:

• Lead and execute global CMC regulatory strategies across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle activities
• Provide strategic regulatory guidance to Manufacturing and Quality teams to ensure global compliance and readiness for clinical and commercial supply
• Oversee the planning, development, and delivery of CMC sections for global regulatory submissions, including responses to Health Authority (HA) questions
• Manage regulatory activities related to clinical and commercial manufacturing changes, ensuring alignment with global requirements
• Ensure CMC regulatory content aligns with evolving regulatory expectations, guidance, and policy trends across regions
• Coordinate global submissions, product registration maintenance, and change control activities throughout the product lifecycle
• Partner cross-functionally with Manufacturing, Quality, Clinical Operations, and Program Teams to deliver key regulatory milestones
• Proactively identify regulatory risks and develop mitigation strategies to support program success
• Leverage deep regulatory expertise to anticipate challenges and drive effective, forward-looking solutions
• Contribute to organizational regulatory knowledge by sharing insights, lessons learned, and best practices

Education and Skills Requirements:

• Bachelor’s degree in Life Sciences or a related scientific discipline required; advanced degree (MS/PhD) preferred
• Minimum of 10+ years of experience in biotechnology or pharmaceutical industry, including at least 7+ years in Regulatory Affairs with strong focus on CMC
• Demonstrated experience leading CMC sections of global regulatory submissions, including biologics marketing applications (BLA/MAA)
• Strong experience supporting global regulatory filings and health authority interactions (e.g., FDA, EMA, and other international agencies)
• Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management
• Strong working knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks
• Experience with EU and international regulatory requirements for both clinical and commercial programs is preferred
• Extensive experience with CTD structure, content, and global submission requirements
• Proven ability to independently manage multiple complex regulatory programs in a fast-paced environment
• Strong strategic thinking and problem-solving skills, with the ability to balance scientific, operational, and regulatory considerations
• Excellent written and verbal communication skills, including regulatory writing and executive-level communication
• Demonstrated ability to influence cross-functional stakeholders and senior leadership without direct authority
• High level of attention to detail with strong commitment to quality and compliance
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
• Ability to work independently and operate in a highly autonomous manner with minimal oversight
• Candidates must demonstrate recent, hands-on experience supporting CMC regulatory activities within regulated life sciences environments

Engagement Details:

• Contract Duration: 12-month contract with potential for extension based on performance and business needs
• Engagement Type: Full-time contractor (FTE-equivalent)
• Time Zone Required: EST hours
• Location / Delivery Model: Primarily remote, with potential for occasional on-site presence in Waltham, MA as needed
• Travel: May be required for end-user training and key project phases

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***