Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia
Posted Date: Jul 2 2024
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans.
In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency.
Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
Key Responsibilities:
- Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
- Implement the regional strategy(s) in support of the project globally.
- Lead regulatory interactions and the review processes in local region.
- Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
- Ensure compliance with global/ regional requirements at all stages of product life.
- Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.
Basic Qualifications:
- BSc in Biological or Healthcare Science.
- Experience of all phases of the drug development process in regulatory affairs preferred.
- Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
- Experience in relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine.
Preferred Qualifications:
- PhD in Biological or Healthcare Science.
- Capable of leading regional development, submission and approval activities in local region(s).
- Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change.
- Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process.
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion.
- Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long term issues for projects.
- Ability to take sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.
- Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.
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