What are the responsibilities and job description for the Associate Director, Oncology GRA position at GlaxoSmithKline?
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 :
Preferred Qualifications :
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