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Senior Regulatory Affairs Manager
- Permanent
- Operations
- 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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