Job Description

The company HQ is based in Greater Boston, but the role can be fully remote or a Hybrid.

We have a new opportunity graded Director of Regulatory CMC for an amazing organization transforming the lives of patients with serious diseases. Their aim is to develop transformative gene-based medicines based on CRISPR/Cas9 gene editing. They have an established portfolio of programs and they are advancing across their core franchises in immuno-oncology, regenerative medicine, and in vivo and the management team has experience across all aspects of drug development and commercialization. They are now looking for energetic and talented people in Regulatory CMC who like challenges and want to make a difference.

This position will lead and manage regulatory CMC aspects of Cell and Gene Therapy biological products through all phases of development, including MAA/BLA and commercialization.

Reporting directly to the Head of Global Regulatory CMC, the Director, Regulatory Affairs CMC, will be responsible for developing, leading, and implementing global regulatory CMC strategies and the preparation and submission of high-quality CMC sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs). You will provide CMC regulatory support and guidance for assigned projects and interface with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third-party laboratories, global collaborations partners, and contract manufacturers.

Primary Responsibilities Include:

• Serve as regulatory CMC lead for assigned Cell and/or Gene Therapy product(s) for all regulatory CMC responsibilities, including, but not limited to, the development and implementation of regulatory CMC strategy for assigned projects
• As the primary regulatory CMC representative member for assigned projects, provide CMC regulatory guidance for global development and registration programs (e.g., IND/CTA, MAA/BLA). You will also attend internal meetings as well as regulatory agencies meetings
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
• Prepare and deliver CMC dossiers, either with CMC functional areas or hands-on, for clinical trial and registration applications, supplements, and/or amendments
• Manage the review, comments resolution, and approval process to ensure these are ready for transfer to Reg Ops for subsequent activities
• Identify areas to implement innovative regulatory strategies to support company & strategy objectives
• Participates in Global Regulatory Teams and be the key contributor to establishing and implementing the regulatory strategy
• Contribute to, with the ability to own, SOPs and internal regulatory quality procedures
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Regulatory CMC
• Work on objectives that have a critical impact on the functional area and the organization.

Desired Education and Skills: 

• Experience in late-stage regulatory CMC program/project leadership (Phase III IND/CTA, MAA/BLA)
• Direct interactions with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to gene therapy
• Experience working with cell therapy, gene therapy products, or mRNA-based therapeutics is a plus
• This is a hands-on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions
• Experience working in a matrix environment
• Excellent interpersonal, collaboration, written, verbal, and visual communication skills with the ability to influence cross-functionally at all levels within the organization
• Solid sense of accountability, sound judgment, and strong attention to detail.

A good time to Join:

It’s an exciting time to join my client as they continue to grow many of their core R&D functions. You will be joining a Global Regulatory Affairs group that is diversified, fun, friendly, and collaborative, who are eager to take responsibility and make an impact. In return for your time, effort, and expertise, you will receive a competitive salary, bonus, and stock plan (including both RSU’s and Options) plus a benefits package that is generous and comprehensive around time off, healthcare (for you and your family), pension contributions, training support, maintaining a healthy lifestyle, work-life balance and much more. 

To Apply!

To apply for this role, please contact me, Theo Moore on US 587.216.9302 or my colleague Ivan Nash on US 908 378 8980 or press the red “Apply for position” button or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and onboarding experience.”