Senior Regulatory Affairs Manager

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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