- Opportunity to play a key role in shaping the future of Regulatory Affairs.
- Company undergoing a significant transformation
About Our Client
Our client is a well-established pharmaceutical company with an international footprint and a growing focus on innovation, portfolio expansion and general development. The company is investing in new capabilities, strengthening its international presence and enhancing cross-functional collaboration to support the next stage of its growth.The company manages an extensive portfolio across both prescription (Rx) and over-the-counter (OTC)
Role / ResponsibilitiesRegulatory Strategy & Compliance
- Define and execute regulatory strategies for products under development and commercialized products across international markets.
- Lead the planning and execution of regulatory activities including new registrations, variations, renewals and lifecycle management.
- Assess and anticipate the impact of evolving regulatory requirements on the company's portfolio.
- Ensure compliance with applicable regulatory requirements across assigned markets.
- Contribute to regulatory decision-making related to product development, lifecycle management and portfolio initiatives.
Portfolio Management & International Regulatory Activities
- Coordinate regulatory activities across multiple international markets.
- Lead registration projects and maintenance activities for marketing authorizations worldwide.
- Support international product launches, market expansions and product transfer initiatives.
- Collaborate with distributors,
partners and external consultants to ensure successful execution of regulatory plans.
- Monitor regulatory timelines, risks and key deliverables across assigned projects.
Business Development & Strategic Projects
- Participate in regulatory due diligence activities related to licensing, acquisitions and partnership opportunities.
- Assess regulatory risks and opportunities associated with new products and portfolio expansion initiatives.
- Support licensing-in and licensing-out projects from a regulatory perspective.
- Provide regulatory input into strategic business decisions and innovation initiatives.
Cross-Functional Collaboration & Leadership
- Act as a trusted regulatory partner to R&D;, Quality, Medical Affairs, Operations, Supply Chain and Commercial teams.
- Lead and contribute to cross-functional projects involving multiple stakeholders.
- Drive continuous improvement initiatives aimed at enhancing regulatory processes and efficiency.
- Support the ongoing evolution of the Regulatory Affairs function and contribute to building future organizational capabilities.
The Successful Applicant
Profile / Experience
- 8-15 years of experience within Regulatory Affairs in the pharmaceutical industry.
- Solid experience managing international registrations and lifecycle management activities.
- Proven track record developing and implementing regulatory strategies for products in development and commercialized products.
- Experience working across international markets and coordinating activities with external partners and distributors.
- Exposure to licensing activities, regulatory due diligence, portfolio management and/or product transfer projects is highly desirable.
- Experience within corporate or headquarters environments will be particularly valued.
- Strong stakeholder management and influencing capabilities.
- Strategic mindset combined with a hands-on approach.
- Ability to thrive in dynamic and evolving environments.
- Fluent English.
What's On Offer
- Opportunity to join a company undergoing a significant transformation and international growth journey.
- Exposure to a broad and diverse portfolio across both Rx and OTC products, marketed in more than 50 international territories.
- A highly visible role with significant interaction across R&D;, Medical Affairs, Quality, Commercial and senior leadership teams.
- Participation in international projects, portfolio expansion initiatives and strategic business activities.
- The opportunity to make a tangible impact on the future evolution of the Regulatory Affairs function.
- A dynamic environment that encourages collaboration, innovation and professional growth.