Regulatory Affairs Director - Established Products

ENGINEERINGUK; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled regulatory affairs professional to drive regional strategies for a robust portfolio. This role involves ensuring compliance with regulatory requirements while advocating for innovative solutions. The ideal candidate will have extensive experience in drug development and a strong track record of leadership in regulatory interactions. Join a dynamic team dedicated to improving health outcomes through science and technology, and help shape the future of biopharma in a collaborative and inclusive environment.

Qualifications

• 5+ years of regulatory affairs experience in the industry.
• Proven leadership in regional development and submission activities.

Responsibilities

• Develop and deliver regional and global regulatory strategies.
• Lead interactions with local and regional regulatory authorities.

Skills

Regulatory Affairs

Leadership

Regulatory Compliance

Drug Development

Advocacy

Education

Bachelor's Degree

PhD or Master's in Life Sciences or Pharmacy

Job description

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Site Name: UK - London - New Oxford Street
Posted Date: Apr 28 2025

Job Purpose

Ensure the development of appropriate regional regulatory strategy(ies) and their execution for assigned asset(s) consistent with the strategic activities for GSK's Established Products (EP) portfolio. Maintain/ensure compliance with internal GSK processes/policies and regional regulatory requirements.

Key Responsibilities

• Accountable to the Senior/Executive Director for developing and delivering regional and/or global regulatory strategies.
• Lead interactions with local/regional regulatory authorities.

Additional responsibilities include implementing regional strategies, leading regulatory interactions, ensuring compliance, advocating persuasively to senior leaders and authorities, and assessing potential in license molecules.

Why you?

Basic Qualifications:

• Bachelor's degree
• 5+ years industry regulatory affairs experience
• 5+ years leading matrixed teams across global regions

Preferred Qualifications:

• PhD or Master's in life sciences or pharmacy
• Strong technical knowledge of regulatory compliance
• Experience with regulatory officials and advocacy
• Extensive drug development regulatory experience
• Proven leadership in regional development, submission, and approval activities
• Knowledge of clinical trial and licensing requirements globally

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to combat disease, focusing on vaccines, medicines, and the immune system. We value our people and aim to create an inclusive environment where everyone can thrive. Join us in our journey to get Ahead Together.