Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)

Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence
Posted Date: Dec 3 2024

Job Purpose

Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. 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 labeling, commensurate with the available data.

Key Responsibilities

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the lead for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.

• Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally • Implement the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensure appropriate interaction with regional commercial teams in local region
• Ensure compliance with regional requirements at all stages of product life from C2MD
• Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
• Capable of providing assessment of potential in license molecules

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree
• 5+ years of experience in Regulatory Affairs in a regulated environment

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence.
• Proven experience of leading regional development, submission and approval activities in local region(s). Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority
• Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally.
• Extensive knowledge of relevant area of medicine, or proven track record of being able to develop product / therapeutic knowledge in new area
• 10+ years of experience in Regulatory Affairs preferably with infectious disease
• Advanced Scientific Degree

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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