Senior Regulatory Affairs Manager
- Experience Level
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 ResponsibilitiesDrawing up the regulatory strategy for pre-clinical and clinical product development in collaboration with internal functions and potentially also external consultantsDay-to-day regulatory support of our therapeutic area teamsAdvising the program teams and the preclinical and clinical departments on the planning of health authority interactions during the product development processDrawing 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 meetingsMonitoring compliance with regulatory requirements and schedulesIncorporating regulatory requirements in preclinical and clinical developmentResponding to deficiency letters from health authoritiesSupporting due diligence and partnering activitiesIdentifying new regulatory requirements through ongoing further trainingIncorporating 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 ExperienceUniversity or college degree and preferably a doctorate in the field of natural sciences, biotechnology, pharmacy, veterinary medicine or medicineProfessional 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 guidanceExperience 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 advantageBusiness-fluent written and spoken English and preferably also German
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.