CMC PM

A leading pharmaceutical company that accelerates the launch and listing of drugs across China is seeking a CMC PM to join their office in Shanghai. The organisation, which is a subsidiary of an international pharmaceutical corporation, specialises in increasing China's core competitive power in the innovation of new drugs. This is an exciting opportunity to work with a prestigious company that develops first-class drugs.

The CMC will play a key role in aligning project progress and regulatory compliance within all CMC functions and keep effective communication with cross departmental teams. Their key responsibility will be in overseeing CMC project tracking with information from each functional team (Medchem, Tox, DMPK, clinical teams, CMC functions of API, analytic, DP, and supply chain).

Job Responsibilities:

• Overseeing projects from development stage to NDA approval, in terms of CMC Regulatory strategies, timeline management, and budget control.
• Organizing and facilitating CMC Team meetings and is responsible for project tracking, and present progress at Project Monthly Review.
• Implementing gate reviews of CMC-RA filing documents.
• Engaging and interacting with regulatory agencies and internal RA colleagues to reach aligned pathways for all CMC submissions in compliance with applicable regulations and guidelines.
• Ensuring the production and maintenance of requisite developmental reports to ensure delivery of the overall CMC milestones.
• Collaborating with different functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.
• Working within the cross-project community to develop training programs for CMC colleagues.

Skills and Requirements:

• Master or Ph.D. in Chemistry, Pharmaceutical, or related science degree.
• Familiar with CMC-related filing regulations and guidelines.
• Hands on experience in CMC research or production activities such as chemistry, formulation, or analytical development.
• Experience in managing CMC projects in various stages: starting from discovery, pre-formulation study, GLP Tox batch, GMP batch, IND filing, Phase I to III supply, and NDA filing.
• Experienced in IT tools for timeline management and conference presentation.
• 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 Lily Zhao at +86 21 51694106 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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