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Regulatory Consultant, UK Affiliate

Middlesex   •  £50 - £70 per hour  •  Contract/Temporary, Full time


We are currently searching for 3 UK Affiliate Regulatory Managers to join our client on an initial 6 month contract basis, with potential to extend. You will ideally have both post approval and hands on publishing experience, working with the MHRA.

 

Responsibilities:

  • Work closely with global and local colleagues to agree on regulatory data requirements. 
  • Critically evaluate submission packages in line with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA Applications within agreed timeframes
  • Monitor and influence assessment process to expedite and optimise the outcome of their submissions.
  • Drive negotiations with the MHRA to ensure best possible outcome which may include for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
  • Ensure Communication of any regulatory changes to the business as necessary to support licence compliance
  • Submission and maintenance of official local drug information, including Patient Information Leaflets, SmPCs, packaging texts, RMPs and their Educational Material.
  • Assist Senior RA team members with new MA submissions e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness

 

Clients:

  • Provide regulatory advice to global and UK business on all aspects of maintenance work including advice on data requirements, medicines legislation/guidelines, to ensure informed decision making and best chance of optimal assessment timing and outcome.
  • Provides support for divestment and in-licensing opportunities.
  • Proactively builds relationships externally (MHRA) and internally (BF, Med Info, TechOps, Patient Safety, Global colleagues), so that business needs are met.

 

About You:

  • Contribute to the continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
  • Self-initiates personal development opportunities
  • Relies on instructions and pre-established guidelines to perform the functions of the job.

 

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Contact: Tim Barratt
  • Phone: 01727811634
  • Reference: BH-25892
  • Posted: 14th July 2021
  • Expires: 11th August 2021

Achieva Group Limited

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