Regulatory Affairs CMC Manager

ProClinical is advertising a vacancy for a Regulatory Affairs CMC Manager position with a leading pharmaceutical company. Based in Munich, this is an exciting opportunity to work with an illustrious organisation and bolster a career in the Regulatory field. They CMC Manager will work in the product development team and oversee the CMC activities whilst working closely with the QA and Manufacturing teams.

Job Responsibilities:

• Authoring and overseeing the preparation of CMC documentation.
• Overseeing CMC strategy within the team and managing junior members of staff.
• Preparing IMPDs and responses to health authorities.
• Providing assessments of post-approval changes.

Skills and Requirements:

• A Life Sciences degree.
• AT least 5 years with Regulatory Affairs and CMC, in either small or large molecule development.
• Experience liaising with German Health Authorities is a plus.
• English is essential, German is a plus.
• 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 Hugh Pickerill at +44 203 854 1079 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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