Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence
Posted Date: Jan 13 2025
Job Purpose
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.
Key Responsibilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the lead for regional and global regulatory strategy(ies). 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 closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
* Ensure the regulatory strategy 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 regional commercial teams in local region.
* Ensure compliance with regional requirements at all stages of product life from C2MD.
* Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
* Capable of providing assessment of potential in license molecules.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor’s degree
* 5+ years of experience in Regulatory Affairs in a regulated environment
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
* Proven experience of leading regional development, submission and approval activities in local region(s). Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority.
* Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
* Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area.
* 10+ years of experience in Regulatory Affairs preferably with infectious disease.
* Advanced Scientific Degree.
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