Site Name: USA - Maryland - Rockville
Posted Date: Jun 27 2024
Job Purpose:
Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Asset Profile, commensurate with the available data.
Responsibilities:
- Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans.
- Planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency.
- Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data.
- Lead interactions with local / regional regulatory authorities.
- Proactively developing regulatory strategy, considering the needs of other regions globally.
- Implementation of the regional strategy(s) in support of the project globally.
- Lead regulatory interactions and the review processes for assigned asset strategy.
- Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable.
- Ensuring compliance with global/ regional requirements at all stages of product life cycle.
- Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.
Basic Qualifications:
- Bachelor's Degree.
- Experience of all phases of the drug development process in Regulatory Affairs preferred.
- Knowledge of clinical trial and licensing requirements in all major countries (EU, US, JP, China) and ideally knowledge of other key Agency processes globally.
- Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine.
Preferred Qualifications:
- Capable of leading regulatory development, submission, and approval activities in assigned region(s).
- Higher degree preferred in biological or healthcare science.
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