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Regulatory Affairs Manager EU HIV

  • Location

    Cambridge, Cambridgeshire

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    25246_1631622846

  • Published:

    8 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Affairs Manager EU HIV

A top 15 Pharmaceutical company are looking to hire a Regulatory Affairs Manager. This is an EU-focused position working across an HIV portfolio.

Responsibilities:

  • Co-ordinate regulatory submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • For investigational medicinal products, prepare and co-ordinate regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans
  • Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the marketing authorization.
  • For licenced products, prepare and/or co-ordinate the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the Marketing Authorisation Holder via the European Centralised procedure, e.g. PIP commitments, variations, responses to questions, PSURs etc.

Requirements:

  • Life Science degree and demonstrated relevant regulatory affairs experience
  • Good knowledge of regulatory requirements for the EU centralised procedure
  • Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
  • Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
  • Experience in working with document management systems

Salary and benefits:

A competitive salary, annual bonus, initial stock reward, annual stock reward and a wider benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk