Associate Director BIO CMC / EU Regulatory CMC Lead – M4 Corridor

Reference: JM10583R1

Expiry Date: 20-07-2022

Categories Biotech, Manufacturing / Production, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

My team and I would like to introduce to you a new exciting opportunity to join an EU medium sized Biotech that is now looking for an Associate Regulatory Director CMC Regulatory Affairs in to join their team. The role is in a company where the global regulatory CMC leads and this career pathway, are based in the UK and Europe! This is rare in the UK. Even Managers and Senior Managers learn and develop on US and European submissions, so if you want to broaden your regional experiences, this is a good place to begin!

POST-COVID: the official company policy is after Covid you can work from home 3 to 4 days a week as standard.

About the Client:

The company’s vision underpins the ambition to transform lives of the people with rare and severe diseases for good and the focus is always on the patients. They are a research-based bio-pharmaceutical, with a good count of marketed products and one of the first to register a mAb in Europe but now are supporting multiple mAbs and recombinants in Phase 1-3, for global development as well as preparing first BLA/MAAs.

They are very open to hiring both development and lifecycle CMC regulatory specialists with biologicals experience.

What the role is about:

At this role, you will co-lead with the GRL global submissions for all phases of the product life-cycle (Ph. 1-3), MAA, BLA, NDA and Post-Approval for biologicals. You will help your team in setting the CMC regulatory strategies and plans, as well as steer and author key dossiers for new CMC submissions for both DS and DP. Your will at some point lead in matrix depending upon the clinical phase or project assignment and hence will already have started coaching more junior individuals.

As an Associate Director, you will support Health Authorities interactions and HA questions and response to CMC questions, shape or define the CMC regulatory strategy for your assigned NBEs and work with MSAT and the CMC subteam on generation of solid data and risk mitigation.

Your experience and skills:

Our client is looking for individuals with <> 7 years in Regulatory CMC with a proven track of successful leadership, authoring and contribution in delivering CMC sections of new MAA, CTA and PA submissions for biologicals primarily.

Package and Benefits:

The Company is located on the M4 Corridor / West London / Bucks / Herts West area and the package includes a very decent basic salary with 15% bonus with personal and company multipliers, 15% Long term incentive, stock options plan that will grow with you every year, and a car allowance!


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to I will support you throughout the interview and on-boarding experience.

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