In this (Associate) Director role, you will be supporting customer’s CMC-related regulatory activities for assigned products/projects. You will play a leading role in developing regulatory strategies and contribute to the preparation of submission documentation for the life cycle management of new development and approved products, across multiple therapeutic areas.
The responsibilities of the role include:
• Significant support or leading preparation and/or review of EU/UK CMC documentation for submission to Health Authorities e.g., CTAs (IMPDs), substantial modifications, MAAs, post-approval variations, scientific advice briefing documents, paediatric investigation plans (PIPs) and response to health authority questions for assigned projects/products.
• Leading interactions with Health Authorities to agree CMC regulatory strategies and data requirements to facilitate successful approval of assigned products/projects.
• Anticipate when and how regulatory issues may impact the business and diligently and quickly advise project teams and management accordingly.
• Working with global multi-disciplinary teams, as well as CMC technical functions and contract manufacturing organisations (CMOs), providing expertise on CMC/Quality regulations, guidelines and data requirements to meet agency requirements.
• Contribute to CMC process initiatives to support the creation of internal global and local standard operating procedures and guidance documents.
• Provide training and guidance to less experienced members of the EU CMC regulatory team.
To be successful in this position they need you to be a team player, a great communicator and someone with recognised outstanding regulatory, scientific and technical CMC experience gained in leading CMC regulatory affairs roles, covering the following areas:
• Experience of small molecule dosage forms. Familiarity with biological products would be an advantage.
• Significant experience supporting early and late phase clinical development projects, with experience of IMPD preparation for clinical trial applications.
• Understanding of eCTD requirements and experience with preparation of CMC documentation for new product EU MAAs (i.e. Module 3, Module 2 QOS, Module 1 Quality related administrative documents).
• Experience authoring post-approval variations for CMC changes.
• Extensive and demonstrable knowledge of EMA and ICH regulatory CMC/Quality guidelines applicable across the product life cycle.
• Familiar with age-appropriate paediatric formulation requirements and supporting preparation of CMC sections for PIPs.
• Preparation of scientific advice briefing documents for CMC /Quality related content and/or questions. Direct agency interactions with the EMA, MHRA, and with other health authorities and regulatory agencies such as Afssaps, BfArM, IPA will be an advantage.
You need 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 our customer.