Manager, Regulatory Affairs

Manager, Regulatory Affairs

Gilead

London, United Kingdom

The role:

An affiliate Regulatory Affairs role, the Regulatory Affairs Manager will assist in the local coordination and execution of regulatory submissions in compliance with Gilead’s corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.

Reporting to the Associate Director for Liver Diseases, the core elements of this pivotal role will include supporting local execution of the EU regional regulatory strategy, including clinical trial application (CTA) submissions and of the UK and Ireland affiliate commercial strategy.

Specific Job Requirements:

  • Expert on regulatory information and intelligence within the UK and Ireland;;
  • Responsible for coordination with multiple stakeholders national submissions and follow-up of all regulatory submissions, such as variations and clinical trials
  • Reviewer for promotional and non-promotional activities and materials and ensuring their compliance with local guidance, codes of conduct and Gilead SOPs;
  • Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives;
  • Initiates or contribute to local process improvement initiatives and subsequent procedural document development;
  • Provide regulatory expertise for local business initiatives including market access, business compliance and medical led projects;
  • Responsible for ensuring product packaging and associated information is updated and maintained in accordance with product SmPCs;
  • Develop expertise in assign Therapeutic Area, and become Subject Matter Expert (SME) for assigned core Regulatory activities;
  • Responsible under guidance of line manager for own self-development and acquisition of required regulatory skills and knowledge.

Knowledge, Experience & Skills:

  • Demonstrable experience in Regulatory Affairs, in an affiliate or global role, or other relevant industry experience;
  • Science degree, ideally Masters and/or relevant experience in Regulatory Affairs;
  • Knowledge and awareness of the relevant regulatory guidelines and legislation;
  • Highly experienced in filing national variations with MHRA, ideally with an interest or experience in eCTD, publishing and use of electronic portals;
  • Experience in management of CTAs including amendments and other CT related submissions;
  • Experience in GxP compliance;
  • Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice would be advantageous;
  • Expert project management and time management;
  • Excellent organization and interpersonal skills;
  • Excellent verbal and written communication skills in English;
  • Is recognized as a knowledgeable resource within the department on a range of regulatory topics;
  • Able to work equally well as part of a team or independently.

Behaviours, Capabilities:

  • Strong teamwork and facilitation – effective at being a member of teams. Listens actively and responds constructively to needs and views of others;
  • Delivery – gets the job done. Meets or exceeds expectations and exhibits a sense of urgency on critical time-dependent issues;
  • Demonstrates the ability to prioritize and work autonomously;
  • Persists despite obstacles and opposition;
  • Driven – self-drive to identify, initiate and implement projects and processes to address issues.

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© EuroJobsites 2019

EuroJobsites is a 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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