Job Offer – Head of Quality and Regulatory Affairs
Spinofrin is an innovative company developing a process for optimizing active pharmaceutical ingredients. Already awarded by the i-Lab competition and having just completed a second fundraising round, allowing it to ensure its development, Spinofrin wishes to recruit its Head of Quality and Regulatory Affairs manager to strengthen its team.
Spinofrin begins industrializing its process and setting up a dedicated GMP production site. We are looking for the best talents, passionate about entrepreneurship and technology, and who want to get involved in a subject of importance for public health and the European capacity to produce innovative pharmaceutical active ingredients. This exceptional opportunity allows you to be part of an entrepreneurial adventure by participating in the construction of an extremely promising business, based on cutting-edge research.
If you want to become an entrepreneur and join a high growth company supported by technological innovation, send your CV to: email@example.com
Under the direct responsibility of the Chairman, you will be required to take charge of and lead all the regulatory activities necessary to ensure the launch of our GMP production site:
- Definition of the company’s regulatory strategic axes according to current legislation
- Responsibility for the constitution and monitoring of regulatory file
- Implementation and continuous improvement of the quality management system
- Support to the R&D department for the identification of regulatory constraints in the feasibility phase
- Coordination of relations with health authorities and experts
- Development and management of the Quality and Regulatory Affairs team
Location: near Saint-Louis / Bâle (Alsace)
5 to 10 years of experience in Regulatory Affairs in the pharmaceutical production sector.
- Have a global vision of the priorities of the pharmaceutical industry / Health industries: from early access to innovation
- Know how to work in a regulated and complex environment in perpetual evolution
- Have interpersonal skills and know how to develop a network, bring it together and maintain it
- Have operational and professional English both oral and written
- Have writing and oral skills and know how to adapt their speech to different targets
- Master the various national and European laws applicable to drugs, biological products and medical devices.
- Have scientific and regulatory expertise related to the analysis of risks on the life cycle of drugs / health products
- Create, implement and optimize internal business processes
- Contribute to research and development of health products
- Understand pharmaceutical responsibility, risk management
- Develop a strategic and operational vision
- An exceptional adventure in the design and development of an innovative process
- A dynamic, pragmatic and experienced team
- An attractive salary package
- Management opportunities to support the growth of the company
- Unprecedented growth, both personal and professional, with a multidisciplinary team