Senior Regulatory Affairs Officer - Hertfordshire, United Kingdom - Blackfield Associates

Blackfield Associates

Verified Company

Hertfordshire, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

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Description

Are you a Senior Officer/ Associate looking for further progression?

Would you like more responsibility for strategic development?

My client has an exciting opportunity for you; we are looking for a Senior Regulatory Affairs Officer CMC, to join an independent business in Hertfordshire on a permanent basis.

As Senior Regulatory Affairs Officer, you will:

Manage the generation, review, approval and submission of product dossiers and CMC regulatory activities for herbal products. This includes Active Substance Master Files (ASMF) and Drug Master Files (DMF) for products approved country and in Common Technical Document (CTD) format.
Work across multiple teams and secure support from the department leads (R&D, Quality and Production) to ensure that company products, which are developed, manufactured and distributed meet the required standards and legislations and regulatory commitments are met.
Responsible for initiating proactive discussions with regulatory authorities to resolve technical regulatory queries relating to product submission

To be considered for the role of Senior Regulatory Affairs Officer, you will have:

Educated to degree level in a Scientific field
Regulatory experience working with CMC, CTD and ASMF
Experience of QMS system, preferably within a GMP environment

This is a permanent role. Remote working.

For more information or to be considered, please call Rob Carnell on

STR Limited is acting as an Employment Agency in relation to this vacancy.