Manager Regulatory Affairs CMC (Fixed Term) job in Basel

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First Name*

Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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This vacancy has now expired. Please see similar roles below...

Proclinical is working with a fast-growing international specialty pharma company located outside of Basel employing over 300 employees in Switzerland and abroad. This exciting pharmaceutical company is seeking a temporary Manager Regulatory Affairs CMC (maternity cover) to be based in Switzerland on a contract basis.

Job Responsibilities:

Manage and lead assigned regulatory CMC projects incl. management of time-lines and submission planning
Communicate and formulate CMC issues across functional teams
Act as regulatory CMC assessor and strategist
Manage the preparation, writing, and functional review of global CMC documents (modules 3 and 2.3) for new marketing applications, responses to health authorities and post-approval variations
Participate in interdisciplinary change management and evaluate the regulatory relevance of proposed CMC-changes

Skills and Requirements:

University degree in pharmacy, chemistry, life science or similar education
Minimum 4 years' experience in CMC Regulatory Affairs (small molecules) in the pharmaceutical industry
Regulatory CMC knowledge on antibody would be a plus
Solid experience in CTD module 3 handling and life-cycle management of market applications worldwide
Experienced in regulatory CMC assessment
Very good English and German skills (especially CMC writing skills in English)
Reliable team-player which strategic thinking and sense for practical solutions
Good communication skills and able to work independently on multiple tasks and under pressure in an organized manner

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 call Tom Green on +44 203 814 1317 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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