- Opportunity to play a key role in shaping the future of Regulatory Affairs.- Company undergoing a significant transformationAbout Our ClientOur client is a well-established pharmaceutical company with an international footprint and a growing focus on innovation, portfolio expansion and integral 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 DescriptionRole / 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 init

📌 Global Cmc Regulatory Lead Submissions (Les)
🏢 ELM Pharmaceutical Consultancy and pharmacovigilance
📍 Les