Senior Manager, Global Regulatory Affairs

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 data

Responsibilities :

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 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 of all phases of the drug development process in Regulatory Affairs preferred
• Knowledge 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 medicine

Preferred Qualifications :

• Capable of leading regulatory development, submission, and approval activities in assigned region(s)
• Higher degree preferred in biological or healthcare science

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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.

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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