UK, Ireland and Malta Regulatory Affairs Product Lead

Recruiter
Nicholas Howard
Location
Paddington
Posted
18 Apr 2019
Closes
19 May 2019
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time

Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as UK / Ireland and Malta Regulatory Affairs Product Lead.

Based in Paddington, the UK-Ire Regulatory Affairs Product Lead will provide regulatory strategy for the product portfolio in the United Kingdom, Ireland and Malta, within the local business/operating company (LOC). Primary responsibilities include operational regulatory affairs activities, involving interface from LOC to European and Global RA, ensuring conformance to national and EU Drug Laws, maintaining labelling information to internal and external partners, communicating with national regulatory authority and regulatory institutions if required in collaboration with EU strategists, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams.

In addition, the successful candidate will be required to approve specific advertising and promotional materials in accordance with UK/IE national legislation and codes of practice. Responsibilities include ensuring adherence to company standards and local laws.

Education & Experience:

  • BSc/MSc in a scientific discipline. Ph.D. or Pharm.D preferred.
  • Minimum 8 years of experience with multinational companies in Regulatory Affairs.
  • Proven experience and relationship with UK and Ireland Regulatory Authorities.
  • Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies.
  • Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
  • Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence.
  • Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions.
  • Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking.
  • Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions.
  • Ability to handle multiple tasks and work under pressure.
  • Highly organised.

To be considered for this position please apply below.

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