Position:Director/Sr. Director of Regulatory CMC
Location:Charlestown, MA
About the Role
We are seeking a creative and agile regulatory professional to join our collaborative team as the Director/Sr. Director of Regulatory CMC. This pivotal role involves providing leadership for our dynamic portfolio of viral vector gene therapy programs. The successful candidate will be instrumental in CMC-focused Agency interactions, submission writing, and developing innovative regulatory CMC strategies to support gene therapy development.
Key Responsibilities
- Lead global Regulatory CMC strategic guidance and provide tactical support to development and CMC teams.
- Manage regulatory requirements, interactions, and submissions for CMC activities.
- Engage in internal Regulatory CMC activities and contribute to shaping the broader cell & gene therapy regulatory community through participation in trade organizations.
What We’re Looking For
- A proactive and collaborative individual eager to make a significant impact in the field of gene therapy.
- Strong interest in participating in trade organizations to influence the regulatory landscape.
Education and Skill Requirements
Educational Background:
- Bachelor’s degree in a scientific discipline is required.
- Advanced degrees such as a Master’s, PharmD, or PhD are highly preferred.
Experience:
- At least 5 years of relevant experience in CMC Regulatory Affairs for biologics, including involvement with IND activities, global CTAs, DSURs, and Agency briefing documents both in the US and internationally.
- Experience in gene therapy, cell therapy, or nucleic acid-based therapeutic programs is advantageous.
Knowledge and Skills:
- Comprehensive understanding of current Good Manufacturing Practices (GMP) and familiarity with US and EU drug and biologic regulations and guidelines, including ICH, FDA, and EMA guidelines.
- Proven ability to organize and prioritize tasks effectively to meet established deadlines.
- Capable of working independently as well as collaboratively within project teams and committees to achieve group objectives.
- Exceptional verbal and written communication skills.
- Strong organizational and program management skills, ensuring timely completion of objectives through effective prioritization, scheduling, and task assignment.
- Excellent collaboration skills with multi-disciplinary teams.
- Creative problem-solving and strategic thinking abilities.
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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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