Regulatory Affairs Snr Manager, Global CMC Clinical Lead - Leading IND/IMPD/NDA’s – Remote (East Coast HQ)

Reference: NBUT518

Expiry Date: 30-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Middlesex County
Съединени щати
Remote Working

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Job Description

Location: Remote

Package: Competitive Salary, Bonus, Stock plus benefits with extensive Healthcare and Medical

Our client is a truly global organisation headquartered on the East Coast in Massachusetts, but with offices and manufacturing facilities across the US and Europe. They are pioneers in a number of therapy areas including neurosciences and they manufacture and commercialize products across all modalities including Small Molecules, Biologics, biosimilars & ATMPs.

My client is also well known for recognizing that employees are vitally important to the success of their work to support patients, and the actively foster an environment that empowers employees to build rewarding careers with a cultural belief that innovation is fuelled by diversity of opinions and backgrounds.

Due to the successful expansion of their development pipeline and recent successes in several initial US/EU submissions they are now recruiting for a Regulatory Affairs CMC Senior Manager, to work on Small Molecule investigational products, with a view that these products will be marketed and registered globally. You will be the Regulatory CMC Clinical Lead and the primary global contact for regulatory CMC activities associated with your programs (in Phases 2 and 3), responsible for providing regulatory CMC expertise into the development and implementation of global regulatory strategies, operations, and planning.

The ideal candidate will have proven leadership experience and the ability to work cross-functionally and across different cultures with strong communication and good interpersonal skills. You will also have excellent regulatory CMC knowledge (modules 2.3 and 3) for IND’s and/or IMPD’s and be ready to operate as the Regulatory CMC Lead for investigational products through to NDA.

The role can be remote, with occasional travel expected to Manufacturing sites and/or the corporate HQ, all on the East Coast and on offer is a competitive salary, with a yearly bonus and a lucrative stock package, which is rare at Snr Manager grade.

Position Responsibilities:

  • Providing regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives
  • Preparation and delivery of CMC regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (IND/IMPD/CTAs)
  • 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


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714 or send us a copy of your resume to We will support you throughout the interview and on-boarding experience!

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