REMOTE ** Global Regulatory CMC Lead ** P2 IND/IMPD’s to initial NDA/MAA ** Strategic Role **

Reference: NBUT518A

Expiry Date: 24-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Middlesex County
United States
Remote Working

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Job Description

Our client is a Global Bio-Pharmaceutical company with a successful recent history in bringing innovative therapies for neurological and rare diseases to global markets. They are leaders in many ways and their creativity in matching new formulations and combination products to their marketed products range, has given them a unique advantage in expanding the range of products they can bring to all major Global markets.

At this organization the Regulatory CMC team are a major strategic partner, which means their regulatory CMC roles are focused around providing both regional and global strategic expertise in both early and late-stage development programs. 

We are now recruiting for an experienced Regulatory Affairs CMC Manager/Snr Manager for a Global Regulatory CMC Lead role where you will be the strategic representative for Global Regulatory CMC, for products starting from Phase 2, providing regional and global strategic and operational regulatory CMC expertise through to initial NDA/MAA and in preparation for further global submissions (US, EU, LatAm, AsiaPac and MENA).

You will be responsible for assuming responsibilities from the Global Regulatory Lead, leading, or assisting in delivery of Reg CMC initiatives and the development of Reg CMC strategies in line with the overall global regulatory product strategy.

The package for this role is exceptional and includes a strong basic salary, bonus plus stock with a good vesting period, so the package is bigger and better than most other Snr manager grade roles in Regulatory CMC. The position is also fully remote, with some occasional travel requested to the manufacturing sites on the East Coast, on EST (but not frequent).

Activities - Projects could be in either early-stage or late-stage development:

  • Providing regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams
  • Supporting the preparation and delivery of regulatory submissions IND/IMPD/CTAs and NDA/MAA’s
  • Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise, and accurate submissions to Health Authorities in assigned regions
  • Writing and / or reviewing regional and global CMC submission documents and providing responses to Health Authority questions

Experience needed:

You must have proven leadership and the ability to work cross-functionally and across cultures with strong communication, excellent regulatory CMC knowledge in IND/IMPD’s and competence in leading cross-functional teams, operating within a matrix organizational structure.

If you are looking for a role with an established Bio/Pharma company with a strong and diverse pipeline and history of innovation in CMC and new formulations and modalities, where you will operate as the Lead Regulatory CMC representative on development projects, then this could be the role for you.


To Apply!

To apply for this role, please contact me Theo Moore or Roland Schnapka on US 908.348.6714 or send your CV to and we will respond to you immediately with details on this role. We will support you throughout the interview and on-boarding experience.

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