Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore
Posted Date: Jun 19 2024
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Job Purpose:
Ensure the development and execution of the appropriate regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). 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 labelling commensurate with the available data.
Key Responsibilities:
- Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of appropriate regulatory strategy(ies) according to plans.
- In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (EMA, CBER, PMDA etc).
- Work closely with R&D, Medical and Commercial teams to secure best possible labelling commensurate with the available data.
- Ensuring and driving the regulatory strategy that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
- Provide strategic regulatory input for all development stages of the project/product within a given product portfolio to key stakeholders.
- Liaise closely with other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the Regulatory Matrix Team (RMT).
- Lead regulatory interactions and the review processes in local region e.g. be the point of contact to CBER for the assigned asset(s).
- Ensuring appropriate interaction with regional commercial teams in local region.
- Ensuring compliance with regional requirements at all stages of product life from early development to life cycle activities.
- Proven capability to advocate scientifically sound approaches persuasively to senior leaders in GSK and at Health Authorities.
- Capable of providing assessment of potential in-license vaccines.
Basic Qualifications:
- Bachelor's degree in biological or healthcare science.
- Five or more years of experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
- Three or more years of experience of leading regional development, submission and approval activities in local region(s).
Preferred Qualifications:
- MS or PhD in biological or healthcare science.
- Capable of organising 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 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.
- Ideally also a significant external network at least into other pharmaceutical companies and recognised internally and externally as an expert broadly or in specific areas of regulatory affairs.
- Able to deputise for GRL for assigned assets.
- A solid experience in procedural/registration US regulatory affairs (including as US authorised agent - liaison with US FDA).
- Knowledge in IND and BLA regulations and US regulations pertinent to product development and licensure/post licensure.
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