15 oct
|
Page Executive
|
Madrid
15 oct
Page Executive
Madrid
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 expan
📌 Regulatory Affairs Senior Manager (Madrid)
🏢 Page Executive
📍 Madrid