Regulatory Affairs Collaborator job in Frankfurt am Main, Germany

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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?*

Message

Job type: Permanent

Discipline: Consultant / Specialist

Location: Germany

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

Proclinical has partnered with a mirco-immunotheraphy company in search for a Regulatory Affairs Collaborator. You will oversee ensuring to dispose of the necessary regulatory dossiers in compliance to the regulations of the relevant authorities, of respecting deadlines.

Job Responsibilities

Collaborating to the elaboration of the local registration strategy
Communication with the health authorities (pre- and post-submission)
Adaptation, preparation and writing of the dossiers (module 1 to 5) according to the
national guidelines
Maintenance of the dossiers up to date throughout their lifecycle (variations, renewal,
changes in regulations, etc.)
Redaction and follow up questions/answers with health authorities
Submission of the eCTD format dossiers

Skills and Requirements

Professional experience (at least 3 years) in the regulatory affairs
field for homeopathic human medicines with BfArM
You can analyse, interpret and use legal, regulatory, scientific and technical
information.
Due to the specificity of micro-immunotherapy medicinal products, you are open-minded,
creative and able to elaborate a strategy for registering our medicines in Germany.
You dispose of a very strong autonomy, you are organized, rigorous and persevering.
You are fluent in German and English, both in writing and speaking.

To Apply

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

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