Director, Regulatory Affairs - Specialty Medicine
GSK
Full-time
Remote friendly (Cambridge, MA)
United States
Corporate Functions
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Role Summary
Director, Regulatory Affairs – Specialty Medicine. Lead the development and execution of regulatory strategies for the Specialty Medicines pipeline, ensuring regional regulatory requirements are met and labeling outcomes are optimized.
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: Represent GSK to regulatory agencies and internal stakeholders, advocating for innovative approaches and regulatory solutions.
- Evaluate Opportunities: Provide expert assessments of potential in-licensing opportunities.
Qualifications
- Required: A Bachelor’s degree
- Required: Proven experience in Regulatory Affairs within the pharmaceutical industry
- Required: Hands-on experience with regulatory submissions and interactions with health authorities
- Preferred: Master’s 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
Skills
- Regulatory strategy, submissions, and interactions
- Cross-functional collaboration and stakeholder engagement
- Regulatory compliance and labeling optimization
- Licensing opportunity assessment
Education
- Bachelor’s degree required
- Master’s or PhD in life sciences or pharmacy preferred
Additional Requirements
- Travel and location details are not specified beyond regional responsibilities.