Design. Progress. Together.
CureVac AG is a biopharmaceutical company researching, developing and producing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies and prophylactic vaccines. Currently, about 340 RNA people are striving to achieve our main goal: To bring the first mRNA-based drug worldwide to the market.
To boost our team in Frankfurt/Main or Tübingen, near Stuttgart, we are currently looking to recruit a Life Scientist/Biotechnologist/Pharmacist (f/m) as
Regulatory Affairs Manager (f/m)
Job ID 1902-1801
The Regulatory Affairs Manager (RAM) develops the global regulatory strategy from the start of the preclinical development of product candidates to their approval. The RAM reports directly to the Vice President Regulatory Affairs and interacts closely with the clinical, preclinical, manufacturing and technical development departments.
- Taking responsibility for regulatory / regulatory CMC strategies and day-to-day regulatory support of our therapeutic area teams, technical development and manufacturing departments
- Advising the program teams and the clinical, preclinical, and CMC departments on the planning of health authority interactions during the product development process
- Drawing up and coordinating high-quality regulatory documents (e.g. sections of briefing books for health authority interactions, IMPDs, INDs) in close collaboration with the individual functions
- 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 CMC, 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
- University or college degree and 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 EMA, US and other international regulations as well as the ability to assess regulatory risks/benefits and applicable guidances
- Experience in drawing up and coordinating CMC, preclinical and clinical documents for submission to the health authorities (e.g. CTA and IND, and scientific advice briefing books, IMPD 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 German
- Ability to work independently in a structured way and excellent communication skills
We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.
Design your future with us – become part of the RNA people!
We look forward to receiving your application via our CareerPortal.