Regulatory Affairs Senior Associate

Job Ref: J27522
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 06 July 2018
  • Middlesex, England, UK
  • Competitive
    HOUR
  • Natasha Rollason

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The Role:

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Key Responsibilities:

  • Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing)
  • Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
  • Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
  • Review regional component of the Global Regulatory Plan and provide input to operational deliverables
  • Ensure compliance via timely submissions to regulatory agencies and support RRL in review of promotional materials for commercial activities (ex-US)
  • Collaborate with CROs / partners to support site initiation and coordinate collection of functional documents in support of regulatory applications
  • As appropriate participate in GRT to support execution of regulatory strategy and coordinate QC of regulatory documentation (e.g. briefing packages)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies
  • Approve drug shipment for Company and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,)
  • Support process improvement initiatives, standards development, and metrics

Skills/Experience Required:

  • Minimum graduate level, in any life sciences.
  • EU experience, regional level rather than affiliate level
  • Preparing and submitting CTAs applications. It would be a bonus if they have used the VHP.
  • Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products.
  • 3 years' experience

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673

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
05/08/2018 11:29:44
GBP .