Job Description

Location: Remote working on EST or Hybrid (Boston-based HQ)

We are delighted to present to you a new opportunity titled Director of Regulatory CMC for an amazing organization transforming the lives of patients with serious diseases. Our client has both an established product portfolio and a strong pipeline across a number of key therapeutic areas including Oncology, Immunology, and neurodegenerative diseases.

You will be joining a Global Regulatory Affairs group that is diversified, experienced, friendly, and collaborative, who enjoy broad-based, global strategic leadership roles for projects in all stages of development for US and EU markets, as well as major global expansion markets including China, Japan, and Brazil. The company HQ is based in Greater Boston, but the role can be fully remote if you are on EST. They are now looking for an energetic and technically strong Regulatory Affairs CMC Director who enjoys the challenges that come with a global role. This is a hands-on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions

Our client – It’s a good time to join!

Our client is a forward-looking, world-class R&D organization with a well-established reputation for its open and collaborative approach to innovation. They have an established portfolio of programs and an exciting and growing development pipeline across 4 core therapy areas and it’s an exciting time to join my client as they continue to grow many of their core R&D functions including Regulatory Affairs Global CMC.  

Your role – It’s global!

As the Regulatory Affairs, Global Director of CMC you will be reporting directly to the Head of Global Regulatory CMC with strategic responsibility for several key indications which are both small molecules in early and late stage development and Gene Therapy products in early development.

You will provide experience and leadership to the development teams for 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 collaboration partners, and contract manufacturers.

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, having a positive work-life balance and much more. 

Primary Responsibilities Include:

• Serve as regulatory CMC lead for assigned Small Molecule and Gene Therapy product(s) and handle 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), attending internal meetings as well as regulatory agency 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
• Participate in Global Regulatory Teams as a key contributor
• 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.

Desired Education and Skills: 

• Experience in early and late-stage regulatory CMC program/project leadership (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 small molecules and Oligonucleotides
• 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.

If this role sounds compelling….

If you think your profile would make you an ideal candidate for this position, then please contact me, Theo Moore at Theo@AdvTalent.com or call me directly at 587.216.9302 or send your CV in confidence to CV@AdvTalent.com and we will quickly get in contact with you.