Contractor, Global Regulatory CMC

A major biotechnology company is advertising a vacancy for a Contractor, Global Regulatory CMC position. With an extensive pipeline and commercial portfolio in oncology and immunology, this organisation is offering an exciting opportunity to join their team in Uxbridge. The successful applicant will have the chance to marry their expertise to an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

• Participating in the development of the CMC regulatory strategy for submissions with an emphasis on international regions. These submissions include CTA/MAA regulatory filings.
• Collaborating with Regulatory CMC project leads and other relevant line functions to prepare CMC submission documents, registration dossiers, and responses to health authorities for responsible regions.
• Participating in the regulatory evaluation of CMC change controls by liaising with Regulatory CMC project leads and Regulatory Affairs International to determine regulatory impact for responsible regions.
• With supervision, managing Regulatory CMC activities related to commercial compounds for responsible regions.
• Representing Regulatory CMC on Regulatory Affairs International teams.
• Participating in document review meetings and discussions for responsible regions.
• Developing an internal knowledge base for CMC international activities including submission document requirements and working practice for interacting with country affiliates.

Skills and Requirements:

• Experience with CMC regulatory documents (variations, responses and CTAs) and with registration dossiers for worldwide use.
• Knowledge of ICH guidelines and CMC regulations for international regions.
• Experience in developing global CMC regulatory strategy.
• Experience in managing post approval Regulatory CMC activities globally.
• 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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