MSI Pharma are looking to hire a CMC Regulatory Affairs Specialist for a UK based pharmaceutical firm. This is a contract role and can be worked fully remotely from anywhere in the UK
- Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs marketing authorisation applications and all post approval approval activities
- Accountable for delivering "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant systems and procedures and ensuring submission quality.
- Documenting maintenance and communication of Health Authority approval status.
- Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
- Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
- Ensure the learning from own projects are shared with other colleagues/within the functions.
Education and Experience:
- University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- Knowledge of the drug development process and regulatory submissions.
- Understanding of current regulatory CMC requirements
- Oncology Experience