- 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.
- Bachelor's degree in a science-related field with 5+ 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.
- 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.
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Director Regulatory Affairs, Vaccines - Collegeville, United States - GlaxoSmithKline
Description
Site Name:
USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence
Posted Date:
Apr
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...
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Why GSK?
Please 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 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.
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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
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For more information, please visit GSK's Transparency Reporting For the Record site.
