Senior Regulatory Affairs Manager 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: Operations

Location: Germany

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

A popular pharmaceutical company is in search of an experienced Regulatory Affairs Manager to provide operational support. The German based role will focus on clinical trials and manufacturing initiatives.

Job Responsibilities

Drawing up the regulatory strategy for pre-clinical and clinical product development in collaboration with internal functions and potentially also external consultants
Day-to-day regulatory support of our therapeutic area teams
Advising the program teams and the preclinical and clinical departments on the planning of health authority interactions during the product development process
Drawing up and coordinating high-quality regulatory documents for submission to health authorities in collaborations with the individual functions (e.g. CTA and IND, briefing books for health authority interactions)
Preparing and participating in health authority interactions such as scientific advice or pre-IND meetings
Monitoring compliance with regulatory requirements and schedules
Incorporating regulatory requirements in preclinical and clinical development
Responding to deficiency letters from health authorities
Supporting due diligence and partnering activities
Identifying new regulatory requirements through ongoing further training
Incorporating new regulatory developments in the development strategy and internal work processes, including drawing up and revising work instructions in collaboration with the relevant functions

Skills and Experience

University or college degree and preferably a doctorate in the field of natural sciences, biotechnology, pharmacy, veterinary medicine or medicine
Professional experience with regulatory affairs with the health authorities at national and international level, or in the pharmaceutical industry, including knowledge of licensing requirements and legislation
Knowledge and understanding of European, US and other international regulations as well as the ability to assess regulatory risks/benefits and applicable guidance
Experience in drawing up and coordinating preclinical and clinical documents for submission to the health authorities (e.g. CTA, IND, scientific advice briefing books, etc.)
Regulatory and/or scientific/clinical experience in the area of biologics, ATMPs, vaccines and oncological drugs is an advantage
Business-fluent written and spoken English and preferably also German

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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