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Senior Regulatory Affairs Manager - EU Speciality Medicines

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    25624_1633602714

  • Published:

    10 days ago

  • Consultant:

    Matt Thomas

Job title: Senior Regulatory Affairs Manager - EU Speciality Medicine

A global pharmaceutical company is Essex are seeking a Senior Regulatory Affairs Manager. This role will focus on the development of medicinal products in the EU

Responsibilities:

  • Manage both centralised and/or decentralised filings of Specialty Respiratory medicinal products in EU
  • Ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for EMA or national competent authorities.
  • Contribute to discussions with Rapporteurs, CHMP members, EMA officials and representatives of European Competent Authorities to secure timely approvals with advantageous labelling.
  • Ensure compliance by providing post-marketing support for existing products in Specialty Respiratory portfolio, including co-ordination and preparation of variations to optimise commercial life of products, development of line extensions, and preparation of licence renewal applications.

Requirements:

  • Strong scientific background with at least a BSc degree in life or pharmaceutical/healthcare sciences
  • Substantial European regulatory affairs experience, preferably gained in a European-based company.
  • Experience in managing both new submissions and maintenance work. Experience in pre-MAA activities, in particular clinical development activities, will be a distinct advantage.
  • Specialty experience in the Respiratory therapeutic area is an advantage.
  • Thorough knowledge of the fundamental process and requirements in the areas of pre-MAA R&D (clinical in particular), pre-and post-marketing of medicinal products.

Salary and benefits:

A highly competitive salary, annual bonus, private healthcare and winder 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