Global Regulatory affairs specialist
Principal Regulatory Affairs Opportunity - Global Semaglutide Portfolio
We are supporting a leading global pharmaceutical company in the search for a Principal Regulatory Affairs professional to join a high-profile regulatory team responsible for post-marketing activities across a market-leading chronic disease portfolio.
This position offers the opportunity to play a key role in shaping global regulatory strategy for established and growing products, working across multiple regions and engaging directly with international health authorities. The successful candidate will act as a strategic regulatory partner to cross-functional teams, helping to drive critical regulatory decisions that support both lifecycle management and long-term portfolio objectives.
The role is ideally suited to an experienced Regulatory Affairs professional who enjoys operating at a strategic level, influencing stakeholders, leading complex regulatory discussions, and navigating challenging regulatory scenarios within a fast-paced global environment.
Key Responsibilities
- Develop and execute global regulatory strategies for marketed products
- Lead regulatory assessments and provide strategic guidance throughout the product lifecycle
- Prepare and coordinate Health Authority meeting packages, briefing documents, responses, and regulatory communications
- Represent Regulatory Affairs within global cross-functional project teams
- Drive regulatory strategy discussions and influence key business decisions
- Lead major post-approval submissions, variations, and lifecycle management activities
- Collaborate closely with Clinical, Safety, Quality, CMC, Medical Affairs, Commercial, and senior leadership teams
- Act as a trusted regulatory advisor to internal stakeholders across global markets
- Support regulatory planning and execution for complex and business-critical projects
What We're Looking For
- 8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry
- Strong knowledge of global regulatory frameworks and post-marketing regulatory requirements
- Experience developing regulatory strategies and leading Health Authority interactions
- Background preparing briefing books, meeting packages, and regulatory submissions
- Proven ability to influence stakeholders and work effectively across global matrix organisations
- Excellent communication, leadership, and relationship-building skills
- Ability to balance strategic thinking with hands-on execution
Key Highlights
- Principal-level Regulatory Affairs position
- Permanent full-time opportunity
- Hybrid working model with flexibility
- Focus on post-marketing regulatory strategy for a globally significant product portfolio
- Direct interaction with international Health Authorities
- Opportunity to lead critical regulatory submissions and strategic initiatives
- High visibility role with significant influence across global cross-functional teams
- Informal leadership responsibilities with strong stakeholder engagement and decision-making ownership
- Excellent long-term career development opportunities within a world-class regulatory environment