We are currently looking for a Senior CMC Regulatory Compliance Lead (Regulatory Affairs) to join a leading Life Sciences company based in the Hertfordshire area. As the Senior CMC Regulatory Compliance Llead you will be responsible for Technical Documentation Control and Planning within the Regulatory Affairs Group. You will report into the Regulatory Affairs Director and have accountability for developing and enhancing the organisations capabilities in the areas of drug development, regulatory compliance and leadership.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior CMC Regulatory Compliance Lead will be varied however the key duties and responsibilities are as follows:
1. Based on understanding regulatory requirements, you will be accountable for driving the generation of appropriate and well controlled technical documents, increasing the chances of first time approval and reducing the need for change applications for markets worldwide (primary focus in EU, UK and US).
2. You will develop and lead small team (4) of technical experts who are responsible for writing CMC regulatory documents ensuring required input from scientific staff, including responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents as well as CMC parts of clinical trial applications.
3. Establish in collaboration with the product owners the list of upcoming as well as the supportive documentation required to support the filing of the manufacturing changes. Negotiate and agree with Validation, R&D, Production, Supply Chain, Quality and Engineering the level of data required for submission, and what would rather be nice to have (risk assessment).
4. To drive Regulatory Compliance to a higher standard, the role includes responsibility for checking consistency between data submitted as part of licensing activities and approvals with current manufacturing SOPs.
To be successful in your application to this exciting opportunity as the Senior CMC Regulatory Compliance Lead we are looking to identify the following on your profile and past history:
1. Relevant degree qualification in a Life Science or Scientific related discipline, in addition to extensive Regulatory Affairs experience with exposure to all areas of Regulatory Affairs.
2. Proven industry experience of Regulatory Submissions including the preparation and review of submissions, ideally to a range of markets with exposure to a range of submissions systems. Ideally within a biologics manufacturing environment, however, other Life Sciences and Pharmaceutical experience will also be considered.
3. Extensive knowledge of Regulatory CMC for products in development and manufacture with experience of the management of change control processes.
Key Words: CMC | Regulatory Complaince | Regulatory Affairs | Regulatory CMC | Manufacturing | Pharmaceutical | Biopharmaceutical | Biologics | GMP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.