Director of Regulatory Affairs CMC

BlueRock Therapeutics; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a Regulatory Affairs CMC Lead to oversee regulatory submissions for their innovative cell and gene therapy products. The ideal candidate will have extensive experience in the global pharmaceutical industry, particularly in biologics, and possess strong communication and project management skills. Join an award-winning team committed to developing cutting-edge therapies to improve patient outcomes worldwide.

Qualifications

• 8-10+ years in Regulatory Affairs, CMC, with experience in biologics or cell/gene therapy.
• Proven track record in preparing regulatory filings and leading discussions with global authorities.
• Strong background within a global pharmaceutical/biotech company.

Responsibilities

• Lead regulatory CMC activities for cell and gene therapy pipeline products.
• Provide strategic guidance on regulatory requirements for clinical trials and marketing applications.
• Manage multiple complex projects independently.

Skills

Regulatory Affairs CMC

Biologics

Product Development

International Regulations

Interpersonal Communication

Project Management

Tools

eCTD format

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating new medicines for neurological and ophthalmic diseases. Our investigational therapies include bemdaneprocel (BRT-DA01) for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases. Founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, our culture emphasizes persistence, innovation, integrity, and community.

What Are We Doing?

We leverage foundational science to create and direct the differentiation of pluripotent stem cells into functional cells for allogeneic cellular therapies, with capabilities for further engineering to produce enzymes, antibodies, and proteins for therapeutic benefit. Our mission is to advance cellular and gene therapy to impact millions of patients worldwide.

We seek collaborative individuals who thrive in a dynamic environment and are committed to advancing cutting-edge cellular therapies.

This position reports to the Vice President of Regulatory Affairs and Medical Writing. The role involves providing regulatory CMC leadership for cell and gene therapy products, including preparing dossiers for health authority meetings, INDs/CTAs/IMPDs, and marketing applications internationally. The candidate will work closely with technical teams and participate in global regulatory strategy discussions. Experience in neurology, ophthalmology, cardiovascular areas, and knowledge of global regulations for cell therapy is preferred.

Responsibilities:

• Lead regulatory CMC activities for cell and gene therapy pipeline products.
• Provide strategic guidance on regulatory requirements for clinical trials and marketing applications.
• Manage multiple complex projects independently.
• Coordinate with health authorities on submissions and responses.
• Identify and resolve strategic regulatory issues.
• Interpret global regulations, identify opportunities, and assess risks.
• Review change controls and prepare global CMC submissions, ensuring thoroughness and timeliness.
• Collaborate with diverse teams and utilize electronic systems for dossier management.
• Support departmental initiatives and document preparation.

Minimum Requirements:

• Strong background in Regulatory Affairs CMC within a global pharmaceutical/biotech company, with expertise in biologics, product development, and international regulations.
• 8-10+ years in Regulatory Affairs, CMC, with experience in biologicals or cell/gene therapy products.
• Experience with combination products and device filings is a plus.
• Proven track record in preparing regulatory filings (eCTD format) and leading discussions with global authorities.
• Experience in development, manufacturing, and testing of cell therapeutics is highly desirable.
• Ability to understand manufacturing and quality control aspects and communicate them effectively in regulatory documents.
• Excellent interpersonal, communication, and computer skills (Word, Excel, PowerPoint).
• Willingness to travel up to 25% within US/Canada, with some EU travel possible.

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Company Culture Highlights

Winner of Boston Business Journal's Best Places to Work 2023, Comparably's awards for Diversity, Women, and CEO in 2022, and ranked in the top 5% for overall culture on Comparably.

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Equal Opportunity Workplace: We celebrate diversity and are committed to equal opportunity employment. Please inform us if you require accommodations during the recruitment process.