Putting patients first, being innovative, thinking differently, collectively working together are all fundamentals of client’s culture. With an exciting range of four approved products and a strong portfolio of new indications, products and projects in the pipeline, we are looking for a CMC Regulatory Affairs expert to be part of their dynamic and outstanding team, contributing to the continued success and growth in Europe and the UK.
In this role, you will aspire to support client’s CMC-related regulatory activities for assigned products at different stages of the product life-cycle. This is an exciting, unique and rewarding opportunity to further develop and increase your existing CMC regulatory knowledge, to gain a wider breadth of experience of different submission types. In addition, you will gain valuable insight in other areas of regulatory affairs, from working closely with therapeutic area regulatory affairs colleagues and as an integral member of cross-functional and global project teams. Thus, further promoting your professional development and growth to become an all-round CMC Regulatory Affairs expert.
You will lead and work closely with client’s CMC technical and manufacturing functions to define CMC data, regulatory requirements and strategy, for the preparation of submission documentation for assigned products to primarily support post-approval activities, whilst having the opportunity to further develop knowledge and experience in other aspects of CMC regulatory, which may include supporting: Investigational Medicinal Product Dossiers (IMPDs) for clinal trial applications, EU/UK Marketing Authorisation Applications (MAAs), scientific advice and pediatric product development for Pediatric Investigation Plans (PIPs). In addition, you will contribute to CMC process initiatives to support the creation of internal global and local standard operating procedures and guidance documents.
To be successful in this position we need you to be a team player, a great communicator and someone with recognised experience gained in focused CMC Regulatory Affairs role(s), covering the following areas:
• Robust experience of small molecule dosage forms, particularly sterile and oral products. Familiarity with biological products will be an advantage.
• Robust experience with preparation of documentation for minor and major CMC post-approval variations.
• Experience of extension applications for new strengths and/or pharmaceutical dosage forms.
• Experience with EU submissions via the Centralised Procedure.
• Demonstrable knowledge of EMA and ICH regulatory CMC/Quality guidelines
• Experience supporting the preparation of CMC documentation for IMPDs, new product EU MAAs and PIPs will be an advantage.
• Direct agency interactions and preparation of scientific advice briefing documents for CMC related content and/or questions will be an advantage.
We need you to have a good strategic and technical mindset, the ability to build rapport globally and cross-functionally and be willing to contribute to build a stronger EU Regulatory Affairs function at client.