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Regulatory Affairs Associate Director UK/IE

Regulatory Affairs Associate Director UK/IE

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    23420_1618392238

  • Published:

    6 months ago

  • Expiry date:

    2021-05-14

  • Consultant:

    #

Job title: Regulatory Affairs Associate Director UK/IE

A Global Pharmaceutical company in Essex are recruiting for a Regulatory Affairs Associate Director UK/IE. This role will have responsibility for Regulatory affairs ownership for all new UK and IE Marketing Authorisation submissions for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.

Responsibilities:

  • Full lifecycle management of product allocation including support of all new product launch activities for both UK and IE.
  • Fulfillment of line management related responsibilities for 6 direct reports
  • Ensure R&D receive the regulatory guidance necessary to ensure that responses are submitted on time and that content is aligned with MHRA/HPRA data requirements.
  • Provide regulatory support throughout product development to approval for local co-development initiatives and local in-license of new products
  • Formulate regulatory strategies for all products within the team for new submissions and post approval changes.

Requirements:

  • Experience in regulatory affairs in pharmaceuticals and previous experience of managing teams.
  • Demonstrated experience of contact and relationship with MHRA and HPRA.
  • Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products.
  • A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.

Salary and benefits:

A highly competitive salary, annual bonus, car allowance, private medical and a wider benefits package is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk