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.
Why GSK?
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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