Director, Regulatory Affairs - Specialty Medicine

Role Summary

Director, Regulatory Affairs – Specialty Medicine. Lead the development and execution of regulatory strategies for the Specialty Medicines pipeline, ensuring regulatory compliance and optimal labeling to accelerate patient access.

Responsibilities

• Lead Strategy Development: Design and implement robust regional and global regulatory strategies for assigned assets, aligned with the overall Medicines Development Strategy.
• Be the Key Contact: Act as the primary regulatory point of contact for your asset(s), working across global teams and engaging with local regulatory authorities.
• Drive Regulatory Success: Collaborate with commercial teams to secure optimal labeling and lead regulatory interactions and submissions in your region.
• Ensure Compliance: Maintain full compliance with internal policies and regional regulatory requirements throughout the product lifecycle.
• Influence and Advocate: Confidently represent GSK to regulatory agencies and senior internal stakeholders, advocating for innovative approaches and regulatory solutions.
• Evaluate Opportunities: Provide expert assessments of potential in-licensing opportunities.

Qualifications

• Required: A Bachelor‚Äôs degree
• Required: Proven experience in Regulatory Affairs within the pharmaceutical industry
• Required: Hands-on experience with regulatory submissions and interactions with health authorities
• Preferred: A Master‚Äôs or PhD in life sciences or pharmacy
• Preferred: Strong technical knowledge of regulatory compliance
• Preferred: Excellent communication skills and the ability to influence regulatory officials and internal leaders