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Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    Cheshire

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    £48k per year

  • Contact:

    Jack Clay

  • Contact email:

    Jack.clay@catalystcareers.com

  • Contact phone:

    02035899300

  • Job ref:

    LM48553

  • Published:

    8 months ago

  • Expiry date:

    2020-01-27

Regulatory Affairs Manager

Global Pharma

Job Purpose

The position is responsible for the day-to-day management of UK and Irish medicinal product regulatory licensing activities (MAA's and all national post authorisation activities) along with oversight and management of the client's nutritional products.

Main Accountabilities

  • Day to day management and allocation of workload within the department.
  • Mentoring, coaching and line management activities of the regulatory team.
  • Preparation and submission of regulatory post authorisation activities, such as variations, renewals, new MAA's to MHRA and HPRA.
  • Oversight and management of the enteral nutrition borderline substances to ACBS and DHSC
  • To assist in the management of the regulatory budget / invoicing activities, including tracking of all regulatory expenditure and budgetary spend.
  • Assess provided supporting dossier documentation to ensure adequacy and accuracy for submission.
  • Maintain effective communication between the company and the regulatory authorities during assessment of applications to obtain prompt approval.
  • Maintain effective communication between corporate and regional regulatory colleagues to obtain necessary information / data for regulatory submissions.
  • Assess promotional material against ABPI Code of Practice and relevant national requirements.
  • Assess licensed product labelling to ensure compliance with legal and corporate requirevaments.
  • Provide a professional, responsive and efficient service at all times.
  • To undertake other reasonable duties as assigned by the Head of Regulatory Affairs.

Experience and Qualifications

  • Minimum 6-10 years' experience within pharmaceutical regulatory affairs
  • 2 years' or significant people management experience
  • MAA experience desirable

Keywords

regulatory affairs / pharmaceuticals / nutrition / market authorisation application / post application / MHRA / HPRA / ACBS / DHSC / submission / Renewals / variations