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)
Job Description Role / Responsibilities Regulatory 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.