Director Regulatory Affairs, Vaccines

Job description

Nombre del sítio: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence
Fecha de publicación: Feb 20 2024

Are you looking for a highly visible role where you can ensure the development and execution of appropriate strategies across all stages of the product life cycle consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP)? If so, this role could be an exciting opportunity to explore.

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:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

· 
Ensuring and driving the regulatory strategy that will deliver the needs of the local region(s), taking in to 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.

 Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

· 
Bachelor's degree in a science-related field with 3+ years of regulatory strategy or related experience.

· 
Regulatory affairs experience in at least one therapeutic area throughout early and late development.

· 
Experience in regulatory drug development, including major health authority interactions.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

· 
Advanced degree is preferred.

· 
Preferred experience in Vaccines.

· 
Prior involvement in phase 3 design, including end-of-phase-2 health authority interactions.

· 
Contribution to regulatory approval, leading response teams, and conducting labeling negotiations.

· 
Understanding of guiding principles in drug development such as benefit/risk profile, dose selection, and statistical design.

· 
Critical thinking on global regulatory science questions and understanding of corresponding scientific and clinical components.

· 
Competencies in strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership, and strong oral/written communication skills.

Why GSK?

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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