Alnylam seeks a highly motivated Senior Manager, Regulatory Affairs, to manage the European regulatory activities of products in late stage development through to gaining marketing approvals and post-approval. This Regulatory affiliate role will involve contributing to the development of regulatory strategy for specific projects, including providing support to the set-up of compassionate use programs, review of commercial / medical materials and support for all European launch activities. The individual will also work closely with supply chain and quality assurance to ensure country-specific regulatory compliance.
The role requires an individual who can work collaboratively with teams based across Europe and in the US and is able to communicate effectively in a fast-paced environment.
Located in in Munich, Germany (or Amsterdam, Netherlands) this role will report to the Director, EU Lead, Regulatory Affiliates, based in France.