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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.