Senior Regulatory Affairs Officer

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  • £50,000 to £55,000
  • Permanent
  • Rob Carnell
  • 02392322362
  • Email about this job

Are you a CMC experienced Regulatory Affairs Officer?

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.
* Act as the regulatory contact to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of a new pharmaceutical substances, to expedite submission, review and approval of global CMC applications.
* 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 02392 322362

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



Health Economics & Outcomes Research


Market Access, Pricing & Reimbursement

Medical Affairs

Quality Assurance




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