Regulatory Technical CMC Consultant

A job vacancy for a Regulatory Technical CMC Consultant has arisen at a leading global pharmaceutical company. This German based office is looking for an intelligent and energetic CMC to join their team and focus on the life cycle management of the environment.

Job Responsibilities

• Translation and interpretation of the regulatory and technical requirements of the country concerned into CMC/technical requirements
• Identifying potential pharmaceutical problems and risks
• Carrying out risk assessments and highlighting ways the risks can minimised
• Creation of quality reference files for the affected products
• Commenting, interpreting and implementing CMC-relevant guidelines, guides and pharmacopoeias
• The aim of the activity is to understand the interaction of the life cycle molecules involved and to design the CMC documents according to the interaction.
• As needed, coordinate /collect/store source documentation needed for direct submission to Health Authorities.
• Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
• Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.

Skills and Requirements

• Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
• Advanced Science Degree is desirable.
• Experience in regulatory and/or pharmaceutical industry preferred.
• Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
• Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
• Fluent English required (oral and written). Excellent written/spoken communication skills.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Proficiency in 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 Keri Marshall at 0207 440 0679 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.

#LI-KM2

#RegulatoryAffairs