Pharmaceutical Regulatory Affairs Job Home Counties

Shreeya Patel at CK Clinical is currently recruiting for a Pharmaceutical Regulatory Affairs Manager to join a globally successful pharmaceutical company based in the Home Counties.

Pharmaceutical Regulatory Affairs Manager Job Description

As Pharmaceutical Regulatory Affairs Manager you will:

  • Support the definition of regulatory strategy and subsequent implementation in the Emerging Markets region.
  • Complete lifecycle management activities in line with legal/regulatory requirements and regional business needs.
  • Develop and maintain knowledge of Emerging Markets and EU regulatory procedures and contributes to the effective functioning of the Emerging Markets Regulatory Affairs team.
  • Build and maintain relationships with Regulatory and other staff within the region to ensure effective communication and efficient implementation of regulatory activities.
  • Have line management responsibilities for associates.
  • With some supervision support the definition and communication of regulatory strategy in support of new product registration, in line with commercial objectives.
  • With some supervision, plan and implement regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
  • With some supervision, provide regulatory support for assigned countries.
  • With some supervision, provide appropriate regulatory input to project teams via the Global Liaison and Global Regulatory Teams.
  • Ensure effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications, Variations and Renewals for assigned countries.

Qualifications, Skills and Experience:

To be considered for this Pharmaceutical Regulatory Affairs Manager position, you will have the following qualifications, skills and experience:

  • Life Sciences Graduate, ideally with post-graduate qualification in a relevant area and/or prior experience in product development functions (pharmaceutical development, toxicology, clinical trials, etc).
  • Sound knowledge of principles of Emerging Markets pharmaceutical regulations and guidelines.
  • Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Emerging Markets region.
  • Experience in cross-functional project teams.

How to apply:

Shreeya Patel - Pharmaceutical Regulatory Affairs Recruitment at CK Clinical

Please contact Shreeya for more details.

Click here to apply online now.

For more information regarding this Pharmaceutical Regulatory Affairs Manager position, please contact Shreeya Patel on + 44(0)1438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24228 in all correspondence.

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