Regulatory Affairs Director - Established Products

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Director to lead the development of regulatory strategies for its Established Products portfolio. This role requires a seasoned professional with over 5 years of experience in regulatory affairs and a proven track record of leading teams globally. The ideal candidate will advocate for compliance throughout the product lifecycle and engage with regulatory authorities to ensure successful product approvals. Join a company that values diversity and promotes an inclusive workplace where your expertise will contribute to advancing health on a global scale.

Benefits

Flexible working arrangements

Diversity and wellbeing support

Qualifications

• 5+ years in regulatory affairs with experience leading teams.
• Strong technical knowledge in regulatory compliance and drug development.

Responsibilities

• Develop and deliver regulatory strategies for assigned assets.
• Lead interactions with regulatory authorities and ensure compliance.

Skills

Regulatory Affairs

Leadership

Regulatory Compliance

Communication

Education

Bachelor's Degree

PhD or Master's in Life Sciences or Pharmacy

Job description

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Regulatory Affairs Director - Established Products, London

Client: GSK

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 8eec0871da5e

Job Views: 3

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description:

Job purpose: Ensure the development of appropriate regional regulatory strategies and their execution for assigned assets, consistent with GSK’s Established Products (EP) portfolio. Maintain compliance with internal processes and regional regulatory requirements.

Key Responsibilities:

• Develop and deliver regional and global regulatory strategies, acting as the single point of contact for assigned assets.
• Lead interactions with local/regional regulatory authorities.
• Ensure strategies meet regional needs and support global projects.
• Coordinate with commercial teams for optimal labeling.
• Ensure compliance throughout the product lifecycle.
• Advocate persuasively with senior leaders and health authorities.
• Assess potential of license molecules.

Why you?

Basic Qualifications:

• Bachelor’s degree
• 5+ years in regulatory affairs
• 5+ years leading matrixed teams globally

Preferred Qualifications:

• PhD or Master’s in life sciences or pharmacy
• Strong technical knowledge in regulatory compliance
• Experience interacting with regulatory officials
• Extensive drug development regulatory experience
• Leadership in regional development and approval activities
• Knowledge of clinical trial and licensing in major countries
• Product/therapeutic knowledge in new areas

Why GSK?

GSK is a global biopharma focused on uniting science, technology, and talent to advance health. We aim to be an inclusive workplace where people can thrive and grow, with a commitment to diversity and wellbeing.

GSK is an Equal Opportunity Employer. We support flexible working arrangements. For adjustments or support, contact [emailprotected] or 0808 234 4391.