Global Regulatory Affairs, Director at GlaxoSmithKline

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 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 activitiesProven capability to advocate scientifically sound  approaches persuasively to senior leaders in GSK and at Health AuthoritiesCapable of providing assessment of potential in license vaccinesBasic Qualifications:Bachelor’s degree in biological or healthcare scienceFive 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 scienceCapable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health AuthorityExtensive 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 affairsAble 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 licensurePlease visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees
Why GSK? Uniting science, technology and talent to get ahead of disease together
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 (US Toll Free) or (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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site
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For more information, please visit GSK’s Transparency Reporting For the Record site.SummaryLocation: USA - Maryland - Rockville; USA - Maryland - Baltimore; USA - District of Columbia - Washington DcType: Fulltime