I am actively seeking A Global Regulatory Affairs Manager CMC for an established pharmaceutical company based in Vaud. This is a unique opportunity to join a company experiencing significant international expansion, with an impressive pipeline and portfolio of small molecule APIs supplying partners worldwide. The OpportunityAs Regulatory Affairs CMC Manager, you will play a pivotal role in shaping the company's regulatory strategy and ensuring its innovative products reach patients across diverse markets. This is not just an operational role - it's an opportunity to act as a strategic partner to the business, driving submissions, renewals, and lifecycle maintenance while ensuring compliance in a rapidly evolving regulatory environment. Key ResponsibilitiesLead global CMC regulatory activities for the small molecule API portfolio: New submissions Renewal applications and lifecycle management activities Variations, supplements, and responses to health authority queries. Act as the regulatory voice within cross-functional development and manufacturing teams. Shape regulatory strategies that support the company's long-term growth and global ambitions. Maintain strong engagement with international health authorities, positioning the company as a trusted partner. What's in it for You?Global Reach: Influence submissions and approvals across key markets in Europe, the US, and beyond. Growth Trajectory: Join a company that is expanding rapidly, investing in new technologies and global partnerships. Strategic Impact: Take ownership of a high-visibility portfolio where your decisions directly shape global product availability. Collaborative Culture: Work in a dynamic, international environment where expertise is valued, and career development is supported. Your ProfileDegree in Life Sciences, Pharmacy, Chemistry, or related discipline. Strong track record in CMC Regulatory Affairs, ideally within the API or small molecule space. Solid understanding of EU, Swiss, and FDA guidelines; exposure to other markets highly advantageous. A strategic thinker with the ability to influence stakeholders and manage complex regulatory challenges. Fluent English and French is required.
