Regulatory CMC Specialist

ProClinical is advertising a vacancy for a Regulatory CMC Specialist position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities:

• Accountable within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents.
• Define which CMC documents are required.

• Prepare for and run the CMC Submission Kick Off meeting.
• Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions
• Lead the review process for all CMC documents, consolidating all comments.
• Drive the completion and on-time approval of all CMC documents to submission ready standards.

Skills and Requirements:

• A University degree, preferably Chemistry or Pharmacy.
• Proven experience working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g., ANGEL.
• Expert understanding of the pharmaceutical industry, drug development process, and how they contribute to fulfilling regulatory requirements.
• 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.

To Apply:

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 Numhom Sudsok at +44 203 871 8093 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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