Regulatory Affairs Manager - CMC job in Basel, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: CMC

Location: Switzerland

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

Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel.

Responsibilities:

Offer regulatory assistance for projects and project teams.
Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical (IND/IMPD) and commercial (BLA/MAA) proposals for biologicals.
You will prepare and/or evaluate replies to agency proposal evaluation queries.
Enable and/or attend CMC meetings with crucial shareholders and regulators when suitable such as FDA/EMEA for biologicals.
The ideal candidate will attend customer meetings and project team meetings.
Responsible for preparing source documents for customer RoW proposals, which involves certifications and attestations where suitable.
Other duties may be assigned.

Key Skills and Requirements:

Educated to a degree level in a life science field such as biology, biochemistry, pharmacy, or an advanced degree level.
At least 5 years of experience in preparing and writing CMC sectors for regulatory documents through product lifecycle.
Comprehension of regulatory needs for biologicals.
Familiarity with regulatory affairs within a pharmaceutical setting.
Acquaintance within a CMO/CDMO setting would be beneficial.
Abilities in handling priorities and project timelines.
An organised individual with a high attention to detail.
Fluency in the English and German languages.
Works well within a multifaceted matrix setting.
Interpersonal and communication skills.
Capable of staying calm while under pressure.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 0789542 or p.duvall@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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