• 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.
• 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