Associate Director, Global Regulatory Affairs at GlaxoSmithKline

Job Purpose:Ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s), across all stages of the product life cycle and consistent with Asset Development Strategy /Integrated Asset plan
This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Asset Profile, commensurate with the available dataResponsibilities: Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory strategy(s) and for delivery according to plans
In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP (Vice Presidents) level and representing GSK with at least the local regulatory agency
Work within the larger GSK matrix organization (ie Early/Medicine/Vaccine development Team, Commercial etc) to ensure a robust Regulatory strategy is in place to support particular stage of product life cycle to secure product licensure in key markets identified in the Integrated Asset Plan as well as securing best possible labeling commensurate with the available data
Lead interactions with local / regional regulatory authorities
In performing the role, the job holder will be responsible for:Proactively developing regulatory strategy, considering the needs of other regions globally.Implementation of the regional strategy(s) in support of the project globallyLead regulatory interactions and the review processes for assigned asset strategyEnsuring appropriate interaction with global/regional counterparts and commercial teams where applicableEnsuring compliance with global/ regional requirements at all stages of product life cycle.Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy.Basic Qualifications:Bachelor's DegreeExperience of all phases of the drug development process in Regulatory Affairs preferredKnowledge of clinical trial and licensing requirements in all major countries (EU,US, JP, China) and ideally knowledge of other key Agency processes globally.Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicinePreferred Qualifications: Capable of leading regulatory development, submission, and approval activities in assigned region(s)Higher degree preferred in biological or healthcare sciencePlease 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
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.SummaryLocation: USA - Maryland - RockvilleType: Full time