Director, Regulatory Affairs Global CMC ** Have small molecules but want to gain Gene Therapy exp.? **

Reference: JPC623

Expiry Date: 31-10-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Director, Regulatory Affairs Global CMC role where you lead early and late-stage development projects and NDA/MAA’s planned in the next 12-18 months. Leverage your small molecule experience and work on RNA/Oligonucleotide projects.

Location: Fully remote if you are based on EST

We have an exciting new role for a Regulatory CMC professional experienced in both development and global registrations for small molecules to join our expanding global Bio/Pharmaceutical client in a key role within their Global Regulatory CMC department.

Our client is an established top-50 Bio/Pharmaceutical company with a developed and balanced portfolio of medicines. They currently have over 30 projects in development across their core therapy areas including Oncology, Immunology, and Neurosciences, and their established medicines portfolio is sold in over 160 countries worldwide.

The Global Regulatory CMC department provides Chemistry, Manufacturing, and Controls (CMC) related regulatory expertise for the development and commercialization of small molecules and RNA/Oligonucleotide projects. They develop strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. This will be a full project lifecycle role and includes development projects (IND/CTA’s), US and EU submissions (NDA/MAA’s), and global expansion activities for recently approved products (US & EU) which are now ready for global submissions into the major markets including Brazil, Japan, and China.

The Role

As a director, of Global Regulatory Affairs CMC where you will oversee the development and execution of regulatory CMC development and registration strategies for small molecules and Oligonucleotides. You may manage staff members and lead projects that will be in early and late-stage development as well as operate as the RA CMC lead on global submissions (US/EU/Japan/China/Brazil). As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and operate as the lead RA CMC liaison for the Health Authority interactions.

This role would suit you if you were:

  • An established Director of Regulatory CMC with small molecules looking for a new challenge in a Global role
  • A strong Associate Director looking for an opportunity to move up to Director grade
  • Established in small molecules and now wanting to leverage this experience to move into Gene Therapy
  • Experienced in RA CMC development activities for both US and EU projects but also want to lead/support NDA/MAA’s planned in the next 12-18 months
  • A strong Regulatory CMC professional, who likes to “jump in” and get involved, sharing the workload with a strong team
  • Somebody who can plan, author, review and submit high-quality CMC modules of investigational and marketing authorization filings for small molecules
  • Somebody with the ability to prioritize and respond effectively to program changes; work in a cross-functional team environment and with remote teams; with strong attention to detail and the ability to handle multiple tasks in parallel.

Experienced needed:

  • 10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred
  • Experience providing strategic regulatory guidance to drug development, registration, and global expansion support teams
  • Ability to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
  • Experience in leading Module 3 sections for investigational and marketing applications for small molecules in the US and EU, including responding to FDA/EMA requests and any associated regulatory program management
  • Successful experience authoring CMC documents, leading health authority oral/written communications, and leading CMC-focused meetings is a must.

A strong salary, extensive benefits package including a good stock plan, and full flexibility to work remotely is available for the right candidate if based in the EST zone.

If your profile makes you an ideal candidate for this position, or you are open to hearing about new Regulatory CMC roles at the director level then please contact Theo Moore on US 587.216.9302 or press the red “Apply for position” button and we will reply by return. We will support you throughout the interview and onboarding experience.