- Ensuring and driving the regulatory strategy that will deliver the needs of the assigned US region, 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 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 Biological or Healthcare Science, or related field.
- 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). Capable of organising and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
- Advanced degree in Biological or Healthcare Science, or related field.
- Ten or more years of experience in Regulatory Affairs.
- Extensive knowledge of clinical trial and licensing requirements in region and ideally sound knowledge globally.
- Extensive knowledge and experience interacting with regulatory agencies..
- 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
- Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine
- Scientific basis for development (clinical/ CMC) ideally for vaccines/ biologicals
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Director, Global Regulatory Affairs, Vaccines - Rockville, United States - GSK
Description
Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore.As a Director, Regulatory Affairs, Vaccines you will ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle 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 (FDA/ CBER ). Work closely with R&D, Medical and Commercial teams to secure best possible labelling commensurate with the available data:
Basic Qualifications:
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.
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/ Agencies
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. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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