Regulatory CMC (Senior) Manager
ProClinical is partnering with a pioneering UK pharmaceutical company to announce a vacancy for a Regulatory CMC (Senior) Manager position. This organisation focuses on improving, repurposing, and reinstating drugs to improve their effectiveness and provide patients with more freedom and choice. Due to the fast-growth of their Regulatory department, they are seeking an enthusiastic and talented regulatory affair professional to join their team in the UK.
- Providing expert regulatory CMC input across a range of product types whilst taking regulatory guidelines into account.
- Preparing high quality CMC regulatory documents for small molecule products to support global regulatory submissions and scientific advice briefing documents.
- Interacting with regulatory authorities concerning CMC issues as required for the different markets.
- Providing support and regulatory advice on regulatory CMC issues.
- Mentoring staff on CMC development projects.
- Liaising with internal stakeholders as well as Contract Manufacturing Organisations to assemble and review key quality documents to ensure regulatory compliance.
- Collaborating with the Regulatory Affairs Director to develop Target Product Profile and Regulatory Strategies for the company's products.
- Leading CMC strategy with line management responsibilities for at least one direct report.
- Representing the Regulatory department at internal and external meetings.
- Authoring and reviewing regulatory CMC documents for submissions, including Marketing Authorisation Applications, Lifecycle Management Applications, Clinical Trial documents, and Briefing documents for Scientific Advice Meetings.
Skills and Requirements:
- At least a B.Sc. in a Life Sciences subject, preferably Pharmacy, Chemistry, or related discipline.
- At least 5 years of experience working within CMC in Regulatory Affairs in development and post-approval phases.
- Experience with European regulatory affairs (CP, MRP, DCP). Experience with US-FDA or Rest of World markets would also be beneficial.
- A working understanding of Biopharmaceutics requirements for generics products (e.g. BE study, biowaiver).
- A thorough knowledge of BE trial process; including the interaction between the Regulatory Affairs team with the wider project team, clinical operations, and CROs.
- Knowledge of the evolving regulatory environment, including proposed changes to legislation that may impact the business.
- Capable of expressing a scientific opinion clearly and concisely, defending regulatory decisions under pressure, and presenting findings to a broad audience.
- Capable of working in a team, analysing, and working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Czuprynski on + 44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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