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Regulatory Affairs Manager

Hertfordshire   •  Negotiable  •  Permanent, Full time


Regulatory Affairs Manager

Watford

Flexible/Remote Working

Attractive salary + benefits

Role Summary

- To assist the RA Director to implement the Regulatory Affairs strategy for the EU.

- To undertake regulatory affairs work as required.

- To generate high quality regulatory submissions to target markets throughout Europe in order to deliver a successful and timely portfolio of MA approvals in accordance with the company's requirements.

- Following MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch

Duties/Responsibilities

-Ensure that the new products dossiers are submitted within the agreed timelines

-Submit applications for new products in the UK and EU via national procedure and/or DCP/MRP procedure; 45%

-Prepare and submit responses to queries raised by various agencies in connection with the submitted MA applications.

-Follow up with various Agencies for the approval of the marketing authorisation applications. 2 Maintenance of existing Marketing Authorisations

-Submit Article 61(3) notifications within the MRP/DCP procedures for the allocated products;

-Submit safety variations and update the artworks with the new information for the allocated products (when required);

-Submit administrative and CMC related variations to for the allocated products.

-Plan and submit the renewal applications for allocated products;

-Prepare and submit responses to queries raised by various agencies in connection with variation submissions.

-Follow up regularly with various Agencies for the approval of the submitted variations;

-Submit PSURs for the allocated products. 35% 3 Compliance

-Follow up with various post-approval commitments for the allocated products

-Update the internal RA databases in line with internal SOPs for the allocated products;

-Ensure compliance of the MA with the current regulations.

Education (degree / diploma)

-Scientific degree in Chemistry/Pharmacy/Biology

-Relevant experience in pharmaceutical environment, preferably in generics pharma.

-Minimum 5 years experience in Regulatory Affairs Experience in working in a multicultural environment.

-Knowledge about submissions requirements in the EU.

-Extensive knowledge about regulatory affairs compliance, pharmaceutical chemistry, manufacturing and control.

-Extensive knowledge about product labelling.

-Strong knowledge about EU regulations.

-Ability to work in a matrix organisation

-Critical to be able to manage high stress environment with a solution mind-set.

If you are interested then please do apply or reach out directly at ed.taylor@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-495420
  • Posted: 22nd June 2022
  • Expires: 20th July 2022

Cpl Life Sciences

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