Job Description
We are seeking a creative and agile regulatory professional eager to join a collaborative team as a Director/Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves providing Regulatory CMC leadership for a dynamic portfolio of viral vector gene therapy programs. The candidate will play a key role in CMC-focused agency interactions, submission writing, and developing innovative regulatory CMC strategies that support gene therapy development. The successful candidate will provide global Regulatory CMC strategic guidance and tactical support to development and CMC teams concerning regulatory requirements, regulatory interactions, and submissions for CMC activities. Additionally, the candidate will have the opportunity to participate in trade organizations to help shape the broader cell and gene therapy regulatory landscape.
ResponsibilitiesProvide Regulatory CMC leadership for viral vector gene therapy programs.Engage in CMC-focused agency interactions and submission writing.Develop innovative regulatory CMC strategies supporting gene therapy development.Offer global Regulatory CMC strategic guidance and tactical support to development and CMC teams.Participate in trade organizations to contribute to shaping cell and gene therapy regulatory frameworks.Essential SkillsBachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred.Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs, and agency briefing documents in the US and ex-US.Strong knowledge of current Good Manufacturing Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA, and EMA guidelines.Ability to effectively organize and prioritize tasks to achieve established deadlines.Capacity to work both independently and within project teams to achieve group goals.Additional Skills & QualificationsExperience in gene therapy, cell therapy, or nucleic acid-based therapeutic programs is a plus.Work Environment
This position offers a hybrid work option with a preference for working on-site at our Boston, MA office twice a week.
Pay and Benefits
The pay range for this position is $210000.00 - $235000.00/yr.
health insurance, PTO, 401K, sick time, etc.
Workplace Type
This is a hybrid position in Boston,MA.
Application Deadline
This position is anticipated to close on Sep 15, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.