Job description Posted 20 July 2022

Regulatory Affairs Project Manager

Remote working

12 month initial contract

Pay rate up to £775 per day via Umbrella inside iR35


Who Are We - GSK?

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.


Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:


  • Our values are Patient focus, Transparency, Respect, Integrity
  • Our expectations are Courage, Accountability, Development, Teamwork


Job Purpose

• Responsible for the regulatory management of a portfolio of products across the product lifecycle and is the primary interface with the local regulatory authorities.

• Proactive leadership in defining and implementing effective regulatory strategy, influencing as needed to reflect business needs.

• Responsible for assigned non-product activities of significance to the department /company. These may be of a complex nature.


Key Responsibilities

• Responsible for the regulatory management (delivery and maintenance)of clinical assets and MAs for a a portfolio of products for Ireland and UK

• Is the primary interface with the local regulatory authorities

• Ensure product information is compliant with MA. Ensures that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant with MA and with regulatory requirements

• Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.

• Responsible for the local management of product registration documents in regulatory databases and repositories.

• Manage regulatory agency correspondence in accordance with company procedures

• Notify to Regulatory agencies product quality and safety issues in an expeditious manner in accordance with company procedures

• Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which GSK Ireland is MAH

• Effective planning of regulatory activities for portfolio

• Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.

• Co-ordinates meetings with regulatory authorities and plays a key role in these interactions

• Builds and maintains effective relationships with (not limited to) internal regulatory, medical, commercial, supply chain and clinical groups.

• Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions


Candidate requirements

• In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.

• Knowledge of drug development process and regulatory affairs,

• Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities

• Ability to work in a complex environment

• Good interpersonal and influencing skills