Associate Director CMC Biologics
ProClinical is advertising a vacancy for an Associate Director of CMC Biologics position for a leading global biopharmaceutical company with a historic record of developing medicines and vaccines. The organisation operates in over 140 countries to deliver innovative health solutions through prescription medicines, vaccines, biologic therapies, and animal health products. This is an exciting opportunity for the successful applicant to join this company's team in Switzerland and bring real expertise and direction to the position.
- Leading and driving global CMC regulatory strategies for the assigned products in target regions.
- Taking responsibility for the CMC section of the Regulatory Strategy Document, risk assessment, strategic support, and advice.
- Providing support to the GRL/MPL during Health Authority interactions on CMC issues.
- Being accountable for the global strategy and plan for dossiers related to the assigned projects, such as clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorisation applications, and briefing documentation for Health Authority interactions.
- Overseeing and taking responsibility for providing country specific CMC regulatory requirements for dossier strategies and collaborating with other GRA functions.
- Assessing Change Control Proposals for their regulatory impact worldwide to ensure that regulatory implications for each change control proposal have been considered.
- Reviewing study protocols and reports, as well as other relevant technical documents, intended for the product documentation platform or for local submissions to confirm alignment with the report conclusions with the CMC Dossier Strategy and Plan.
- Being accountable for CMC dossier approval.
- Tracking submissions and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide.
Skills and Requirements:
- At least an MSc or equivalent in a Life Science or related discipline, though a higher degree such as a PhD in a scientific discipline is preferred.
- 7 years of experience in the biopharmaceutical industry, with at least 3 years of global CMC regulatory experience.
- Capable of developing and preparing successful regulatory strategies and dossiers.
- An in-depth knowledge of global pharmaceutical legislation.
- 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 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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