Regulatory Affairs Manager (remote) job in Zug, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

Country*

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*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Project Manager

Location: Switzerland

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

Proclinical are recruiting a Regulatory Affairs Manager for a biotech corporation. This role is on a contract basis with the ability to work remotely in Europe.

Responsibilities:

Handle the relationship with the Clinical Research Organisation contracted for some clinical studies.
Guide the regulatory proposals of clinical trial applications and amendments in Europe such as EU, UK and Switzerland.
You will assist with different regulatory proposals to the marketing authorisations and post-approval measures to the EMA as well as Swissmedic.
Partake in the international regulatory method by bringing the European acumens into conversations.
The ideal candidate will research pertinent regulatory precedent to bring novel approaches to the cross-functional team.
Other duties may be assigned to this role.

Key Skills and Requirements:

At least 5 years of experience in handling regulatory proposals, mainly focusing on clinical trial applications and affiliated duties.
Educated to a degree level in a life science field.
Fluency in the English language.
Familiarity with preparing/proposing regulatory documentation to assist with clinical trial applications/amendments within the EU.
Know-how of the European drug development procedure and regulatory needs.
Comprehension of compliance, and ethical approach to business.
An organised individual with the ability to handle various tasks simultaneously.
A high attention to detail.
Communication skills both verbally and in writing.
Computer literacy with Microsoft Office applications.

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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