Associate Director CMC Biologics
An international biopharmaceutical company is seeking to recruit an Associate Director CMC Biologics to their office in the UK. The company identifies, develops, and commercialises meaningful products that address unmet medical needs. The company is expanding its commercial product portfolio, making this the perfect opportunity to join them and bolster their research and development pipeline in therapeutic areas that can leverage your unique expertise.
- Planning and co-ordinating the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), as assigned.
- Leading functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, and/or late and early stage development programs.
- Solving unique and complex problems that have a broad impact on the function and/or broader department.
- Providing in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges, and/or regulatory issues.
- Interpreting complex technical or supply issues for commercial or development programs for the Global Regulatory Team.
- Regularly interacting with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit, or additional business areas, including regulatory agency interactions.
- Coordinating the preparation and timely submission of responses to regulatory agencies.
- Managing timelines to ensure approvals are timely and development objectives are met.
- Contributing to the development of functional and/or broader department strategy and to departmental plans, including planning, staffing, budgeting, and/or prioritisation
- Identifying and leading continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
- Monitoring EU and US CMC regulations and assessing any changes to ensure all development activities comply with applicable current regulations and guidelines.
- Ensuring continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products.
- Ensuring compliance with company policies, procedures, and training expectations.
Skills and Requirements:
- Demonstrable understanding and strategic application of regulations and guidelines for drug development and commercial supply.
- Demonstrable knowledge of CMC regulatory and ability to generate clear, well-argued positions.
- Extensive experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses, and CTAs/INDs).
- Demonstrable understanding of FDA, EMA and ICH guidelines.
- Ability to influence and impact functional area and department practices.
- 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 with computer skills, such as 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 contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A globally renowned pharmaceutical company is seeking to recruit a Regulatory Clinical Trial Application Submission Manager - Senior to their office in Switzerland.
£0.00 - £60 per hour
An international staffing and recruiting company is currently recruiting a Regulatory Manager - CMC to join their office in the UK.