Manager/Associate Director, Therapeutic Group, Global Regulatory Affairs

GSK Regulatory Affairs Role

GSK, with bold ambitions for patients, aims to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

We are seeking a talented individual with regulatory affairs knowledge/experience and interpersonal skills to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team.

As a valued member of the Regulatory Matrix Team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategies and ensure their execution for assigned assets. This will be consistent with the Medicines Development Strategy/Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile and secures the best possible labelling commensurate with the available data.

Key Responsibilities

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into 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 global/regional counterparts and commercial teams in local region
• Ensure compliance with global/regional requirements at all stages of product life
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset

Why You? Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in Biological Sciences, Healthcare Sciences, or a related field required
• Experience in all phases of the drug development process in regulatory affairs.

Preferred Qualifications:

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

• Advanced degree (e.g., PhD) preferred.
• Knowledge of clinical trials and licensing requirements in all major countries in the region and ideally knowledge of other key agency processes globally.
• Good communicator who can deliver key communications with clarity, impact, and passion.
• Strong listening and comprehension skills, with the ability to proactively identify potential issues and escalate as required.
• Proficient in digital tools and systems to enhance project delivery and drive efficiency and innovation.
• Ability to foster collaborative working relationships and work effectively within cross-functional teams.

Work arrangement:

This role is hybrid. Regular on-site collaboration is expected. Typical schedule will be two to three days on-site per week.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.