Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this role could be an exciting opportunity to explore.
As an Associate Director of Global Regulatory Affairs, you will be responsible for leading regulatory strategy for mRNA Vaccines assets, securing product licensure in key markets identified in the Integrated Asset Plan (IAP) and securing best possible labeling for our Vaccine products.
The Associate Director will be accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate US regulatory strategies and for delivery according to plans. Planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK, and representing GSK with the FDA and possibly other agencies. This role will work within the larger GSK matrix organization (ie. Vaccine development Team, Commercial etc.) to ensure a robust Regulatory strategy is in place to support a particular stage of product development 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.
Responsibilities:
Proactively develop the regulatory strategy, considering the needs of the US and possibly other regions globally
Implementation of the regional strategies in support of the project globally
Lead regulatory interactions and the review processes for assigned asset strategy
Ensuring appropriate interaction with global/regional counterparts and commercial teams where applicable
Ensuring 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 Degree
Experience with all phases of the drug development process in Regulatory Affairs
Experience with clinical trials and licensing requirements in the US
Experience working in a matrix organization
Experience creating a regulatory strategy
Experience securing the best possible labelling
Preferred Qualifications:
Higher degree preferred in biological or healthcare science
Capable of leading regulatory development, submission, and approval activities in assigned region(s)
Experience with clinical trial and licensing requirements in major countries beyond the US and ideally knowledge of other key Agency processes globally.
Knowledge of vaccine regulatory development area
Excellent communication skills
#LI-GSK
The annual base salary for new hires in this position ranges from $134,475 to $224,125 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.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 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.
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