Regulatory Affairs Manager- CTA- EU- 28291

Job Ref: J29502
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 27 November 2018
  • Uxbridge, Middlesex, England, UK UK
  • Competitive
    HOUR
  • Neal Panting
  • 01753 589601
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Consultant on an initial 6 Month basis to be based at their offices in Cambridge or Uxbridge.

The Role:

Maintain all the required licenses in order to support clinical trials and further development of IMPD's; market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety.

Key Responsibilities:

* Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. * Provides content guidance for regional regulatory documents and meetings in accordance with global strategy * Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans) * Supports regional label negotiation activities * Under general supervision participate in the development, and execution of regional regulatory product strategies * Ensures regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders * Communicates regulatory strategies within team * Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies * Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to marketed products. * Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product development.

Skills/Experience Required:

Education

  • Life Sciences Degree qualified.

Knowledge

  • Extensive hands on experience within Regulatory Development.
  • Awareness of registration procedures within the EU including MA's, Post Approval changes, line extensions and renewals.
  • Hands on experience with policies and implementation of SOPs'

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
27/12/2018 13:41:23
GBP .