A fantastic opportunity has become available for a Senior Regulatory CMC Manager to join a fast-growing Biotech company based in the Oxford area. As the Senior Regulatory CMC Manager you will be responsible for the development of the CMC Strategy for all projects within the organisation.
This is a hybrid position, working 2-3 days on-site per week.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory CMC Manager will be varied however the key duties and responsibilities are as follows:
1. The preparation of CMC submissions for investigational products to key regulatory agencies such as the FDA and EMA. You will also be responsible for oversight of CMC document preparation and timelines when subcontracted to a Contract Service Provider.
2. Provide direct liaison with Regulatory Authorities on relevant CMC issues, and the development of any necessary contingencies for CMC submissions in collaboration with internal and external contributors.
3. You will ensure that CMC submissions are of high quality, meet all regulatory requirements and are compliant with corporate goals and directives, providing regulatory feedback to the project teams and senior management.
4. While supporting regulatory inspections, you will establish and update required regulatory quality systems and required Standard Operating Procedures to guarantee the relevant oversight of all internal and external communications.. This role will also work closely with the Clinical Operations Department.
To be successful in your application to this exciting opportunity as the Senior Regulatory CMC Manager we are looking to identify the following on your profile and past history:
1. The successful candidate will be educated to degree level, within a relevant scientific discipline or similar.
2. You will have a wealth of experience within CMC Regulatory Affairs from the Biopharmaceutical industry
3. A working knowledge of Biologics products, their implementation into the market whilst adhering to licensing procedures, with a focus on centralised practices.
Key Words: CMC | Regulatory Affairs | RA | Biotech | Biopharmaceutical | Biologics | CMC submissions
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.