Regulatory Strategist - CMC

Job Ref: J32133
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 03 June 2019
  • Surrey, England, UK Surrey Surrey UK KT20 7NS
  • Competitive
    HOUR
  • Natasha Rollason
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 and is looking to recruit a Regulatory Strategist - CMC on an initial 12 Month contract to be based at either their offices in Surrey or Kent.

The Role:

Accountable for CMC site transfer and other site related change submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets.

Responsibilities:

  • Ensure transparency and excellence in evaluation, definition and execution of regulatory strategies.
  • Ensure dossiers are produced and dispatched to assigned markets according to their defined filing plan, and are submission ready.
  • Maintain systems and databases per internal SOPs and policies.
  • Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead and the Company Country Office) to deliver efficiencies in Regulatory submissions and processes.
  • Manage CMC post approval manufacturing site transfer submissions for the EuCANZ Region (EU, EME and ANZ)
  • Manage post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL/GRS-CMC, PCO, Labelling team, Submissions Management) to ensure a CMC submission ready dossier.
  • Communicate changes to regulatory requirements and update the appropriate system in a timely manner
  • Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners
  • Author local submission components as needed and ensure submission packages are reviewed against local CMC requirements for consistency and completeness
  • Liaise with the manufacturing sites for obtaining supporting documents as needed
  • Ensure thorough understanding and application of GRA procedures
  • Contribute to local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention.
  • Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.

Education & Skills:

  • Bachelor's degree or equivalent in Life Sciences.
  • Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
  • Strong knowledge / background of EU (EU and non-EU) regulatory procedures and requirements Experience
  • Regulatory experience including knowledge of Europe submission product lifecycle management processes.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@SRG.co.uk or +441753 589673

SRG
03/07/2019 11:01:50
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