Job description Posted 26 July 2021

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 assests 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)/ labeling 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

1. Minimum Level of Education*

Graduate/PhD level or equivalent, with experience in the pharmaceutical industry, including regulatory experience.

B. Job-Related Experience

Minimum Level of Job-Related Experience required

•       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


•       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



•       Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.

•       Can define regulatory strategy 

•       Has an in depth understanding of regulatory governance, medical and safety