Regulatory Manager - Global CMC job in Brussels, Belgium

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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 are partnered with a house-hold pharmaceutical business, who are looking to further strengthen their CMC division with a new Regulatory Manager.

You will be supporting all Regulatory CMC Activities across a vaccines portfolio for an initial duration of 12 months.

Skills and Requirements

Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and lead

To Apply

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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