MUST BE BASED IN THE UK TO BE ELIGIBLE.

Job Title: Regulatory Project Manager

Contract Length: 12 Months

Location: GSK HQ, London

Overview

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Role Overview

• 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 portfolio of products for Ireland and UK.
• 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.

 Minimum Requirements

• Graduate/PhD level or equivalent – Life sciences
• Experience in the pharmaceutical industry, including regulatory experience.
• 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

• 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team (EMEA-GSKLink@allegisglobalsolutions.com) to further discuss this today.

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