Regulatory Affairs Professional

Do you have experience in regulatory affairs within the pharmaceutical or biotechnology sectors, developing and managing regulatory submissions and documentation? Can you ensure compliance across the regulatory lifecycle and translate complex requirements into clear, actionable plans? Are you skilled in drug development and able to partner with cross‑functional teams to support timely regulatory approvals? Then you could be the one we are looking for. Join us as a Regulatory Affairs Professional and help ensure safe, compliant, and successful development and approval of medicines. Your new roleAs our new Regulatory Affairs Professional you will be responsible for a wide range of tasks such as:Develop and manage regulatory submissions and documentation across US, EU, and RoW.Plan and coordinate submission and roll-out of Sema NDAs and brand variations.Create content plans for various submission types, including NDAs/MAAs, variations, and supplements.Prepare country-specific Module 1 doc...

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