Regulatory Officer - new job in Reading, UK

Regulatory Officer
  • Competitive
    ANNUM
  • Permanent
  • Reading, Berkshire, England, UK Reading Berkshire UK RG6 1PT
Job Ref: BBBH119835
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 06 January 2023
SRG are currently working with an innovative global healthcare company who are looking for a Senior Regulatory Officer to join their Regulatory Team.

SRG are currently working with an innovative global healthcare company based in Reading. This company aims to improve everyday health for billions of people. By growing and innovating their global portfolio of category-leading brands. They are currently seeking a Senior Regulatory Officer for the General Medicines Business Unit.

In the role you will be responsible for the management of a portfolio of products in line with business goals and legal requirements and will conduct associated regulatory activities for UK and Ireland markets. You will also have the opportunity to lead on cross-functional projects on behalf of UK/IE Regulatory, providing strategic regulatory support to the UK/IE business. Additionally, you will lead in the development of UK/IE regulatory strategy in collaboration with Global/EU Regulatory teams, in particular advising on new UK/GB national regulatory licensing opportunities which have become available post-Brexit. This role presents development opportunities to lead in the recruitment and mentoring of junior Regulatory team members and to broaden your strategic regulatory, product and therapeutic area knowledge.

Responsibilities

  • Co-ordinate, prepare, submit and follow up on registration applications to the UK and/or Irish Regulatory Authorities to ensure that Marketing Authorisations are obtained and maintained in line with the company's plans and goals.
  • Manage the preparation of Marketing Authorisation applications and post-licencing regulatory submissions via national, mutual recognition, decentralised and centralised procedures.
  • Prepare and review labelling, package leaflets and summary of product characteristics etc. to ensure compliance.
  • Work in conjunction with Pharmacovigilance and Medical Affairs to assist in the development and maintenance of Risk Minimisation Materials (RMMs) and Prescribing Information (PI) associated with the Marketing Authorisations.
  • Provide strategic support in the preparation, distribution and follow up of registration documentation required.
  • Demonstrate a comprehensive understanding of the regulatory requirements for marketing authorisations in the UK, Ireland, and EU.
  • Lead on behalf of UK/IE Regulatory in providing strategic regulatory advice to relevant Regulatory and cross-functional colleagues, to assist with product development, lifecycle management and marketing plans.
  • Lead on behalf of UK/IE Regulatory in engaging with supply chain to ensure regulatory strategy is implemented within agreed timeframes.
  • Establish and maintain effective liaison both externally (MHRA and HPRA) and internally across functions within the Business, including Medical Affairs, Marketing and Manufacturing,
  • Lead on the recruitment of student placements and provide mentoring to junior Regulatory team members.

Required Education / Knowledge / Experience

  • Life Sciences Degree, such as Pharmacology, Biology, Biotechnology.
  • Minimum three years proven experience in Regulatory Affairs for Human Medicines, preferably in an Innovator Pharmaceutical company.
  • A comprehensive understanding of UK, IE and EU regulatory procedures for marketing authorisations and submission to regulatory authorities.
  • Experience in leading regulatory projects and initiatives.
  • Administratively well organised, demonstrating attention to detail, strong written and oral communication skills, with the ability to manage multiple projects/priorities under pressure and to tight deadlines.
  • Proven strength in analytical thinking and ability to communicate effectively and efficiently cross-functionally in the business.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/srg-impellam-lock-up-logo---large.png
05/02/2023 17:26:58
GBP 45000 45000 Annum
Contact Consultant:
Corinne Laurence

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