Senior Regulatory Affairs Manager (f/m/d)

60325 Frankfurt am Main, Frankfurt am Main
12.05.2021

Daten dieser Anzeige

Job-ID: 021699839
Senior Regulatory Affairs Manager (f/m/d)

CureVac AG

Germany

https://career.curevac.com/senior-regulatory-affairs-manager-fmd-eng-f894.html?agid=21&utm_campaign=jobware&utm_source=jobware&utm_medium=jobware

Drawing up the regulatory strategy for preclinical 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 collaboration 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

Design. Progress. Together. CureVac AG is a biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies, prophylactic vaccines and molecular therapies. Currently, about 600 RNA people are striving to achieve our main goal: To bring the first mRNA-based drug worldwide to the market. To strengthen our team in Frankfurt, we are currently looking to recruit a Job-ID: 1400-2101 Your responsibilities: Drawing up the regulatory strategy for preclinical 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 collaboration 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 Your qualifications: 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 Ability to work independently in a structured way Excellent communication skills 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. CureVac AG Human Resources Christina Glass Friedrich-Miescher-Straße 15 72076 Tübingen www.curevac.com

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

60325 Frankfurt am Main

Frankfurt am Main