Regulatory Affairs Specialist
We are seeking a seasoned Regulatory Affairs Specialist to join our team. In this pivotal role, you will play a key part in overseeing regulatory activities related to product submissions and approvals in Switzerland.
* Key Responsibilities:
* Develop and implement regulatory strategies for CMC changes, product acquisitions, and due diligence activities. Perform regulatory assessments and manage any resulting regulatory actions in response to change control requests.
* Maintain up-to-date knowledge of CH and EU pharmaceutical regulations, ensuring compliance with evolving regulatory requirements. Develop and maintain internal regulatory SOPs, databases, and IT tools to streamline regulatory processes.
* Collaborate with cross-functional teams, including Medical Information and Pharmacovigilance, to support regulatory activities and ensure regulatory compliance across the organization.
Requirements:
* A master's degree in pharmacy or an equivalent life science field is required.
* A minimum of 5 years of relevant experience in the EU or CH regulatory pharmaceutical environment is necessary.
* Experience in CMC and labelling is essential.
* The ability to prepare and submit eCTD (e-publishing and e-submission system) applications is also crucial.
* Fluency in English is a must, with French being a strong asset.