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Associate Director Regulatory Affairs, Established Products Cambridge United Kingdom,  

Mundipharma Research (company)


Posted on : 22 December 2017

Project Description

Job Introduction

  • Develop and lead regulatory strategies for Mundipharma established products across all therapeutic areas.
  • Provide regulatory advice and expertise to the Independent Associated Companies and commercial Established Brands team.
  • Contribute to the development of people and foster Mundipharma s core values through mentoring, coaching and acting as a role model for all staff in regulatory affairs.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

A.   Specific Duties & Responsibilities

  • Provide regulatory expertise to optimise maintenance activities and geographical expansion strategies on assigned projects 
  •  Work collaboratively with outsource partners to ensure efficient and timely provision of regulatory services to the Independent Associated Companies to maintain and expand the established product portfolio.
  • Plan, coordinate and prepare MA Applications for submission to fulfil commercial expansion plans.
  • Manage the maintenance of MAs via renewals and variations.
  • Coordinate and respond to questions from Regulatory Agencies during MA applications, MA renewals and variations.
  • Provide pharmaceutical, preclinical, clinical and other technical information to our Independent Associated Companies and Licensees, to assist with the registration and maintenance activities of existing MAs.
  • Plan and coordinate responses to regulatory questions relating to the group of Independent Associated companies  products.
  • Advise junior staff on data requirements for their activities.
  • Be aware of and keep up to date with current legislation appropriate to Regulatory Affairs and provide expert advice on items or issues which will affect Regulatory teams. 
  • Take a high degree of personal responsibility for representing the Department both internally and externally.
  • Take a high degree of personal responsibility for decision making and problem solving.
  • Provide expert advice on items or issues which affect the Company.
  • Participate in project teams and provide guidance in areas of expertise for marketed products.
  • Ensure, where appropriate, that the electronic document management system is used for all submission documents.
  • Maintain records of tasks, activities and registered product information in the internal regulatory databases.
  • Take ownership of individual objectives, and be accountable in achieving results while embracing Mundipharma core values.
  • Facilitate teamwork, undertake mentoring and provide guidance to team members as needed.

Key Competencies

.

Main requirements

Qualifications & Experience

Locations

Cambridge (UK)

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