Regulatory Affairs Manager/Senior Associate

Regulatory Affairs Manager/Senior Associate

Gilead

Cambridge, United Kingdom

The Position

An exciting opportunity has become available fo Regulatory Affairs Manager or Senior Associate to join the International Regulatory Affairs team to be based in Cambridge or Stockley Park. This position will report to an Associate Director within the Regulatory Affairs Cell Therapy Oncology Team and will be responsible for the preparation of regulatory submissions for advanced therapy medicinal products that treat cancer:

Key Responsibilities

  • Working with the European regulatory product lead for a development product, prepares regulatory documentation, as required, in accordance with Regulations, guidance and legal obligations;
  • For the development product prepares and/or co-ordination of the regulatory documentation to support clinical trial applications and amendments, in the European Union;
  • Working with the European regulatory product lead to ensure when licensed the product packaging and associated information is updated and maintained in accordance with Marketing Authorisation including the review and management of labelling translations and artwork;
  • Interaction with the Regulatory, Clinical Research, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products;
  • Represents the International Regulatory Affairs function at cross functional submission and study management team meetings;
  • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams;
  • Supports the Associate Director as required.

The successful candidate will have the following

  • Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable or equivalent relevant experience;
  • Experience in the preparation and submission of regulatory documentation to support centralised MAA procedure and post approval activities and a good breadth of understanding of the European regulations;
  • Knowledge and experience relating to clinical trials would also be desirable;
  • Experience representing Regulatory Affairs on cross functional teams is desirable;
  • Excellent planning and organizational skills and the ability to work simultaneously on a number of projects with tight timelines;
  • Excellent communication skills both in writing and verbally;
  • Ability to work under minimal supervision of Regulatory Affairs professionals, but following detailed instruction with well-defined procedures.

Travel

  • Travel will be required between UK sites for meetings and training;
  • European travel would only be required in exceptional circumstances.

Behaviours

  • Resilient profile with the ability to deliver in an ambiguous environment;
  • Ability to engage and manage multiple stakeholders to achieve the business objective;
  • Curious with learning agility;
  • Operationally excellent;
  • Organised with systematic approach to prioritisation;
  • Process orientated to achieve the business objective.

The ideal candidate will align with the company’s core values by being accountable for their work, displaying integrity in everything they do, thriving in a team environment, seeing excellence as the only measure of success, and ensuring inclusion of all viewpoints in decision making.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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