Senior Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Operations
  3. Germany
Frankfurt am Main, Germany
Posting date: 16 Feb 2021
35730

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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