Project Manager Regulatory Affairs - Netherlands
- Regulatory Affairs
- Project Management
Acerca de nuestro cliente
Sanofi Genzyme is one of the world's leading biotechnology organisations, recognised for their pioneering development of treatments for rare genetic disorders and their innovative contributions to medical science and bio-manufacturing. Our client focuses on rare diseases, multiple sclerosis, immunology and oncology. They help people with debilitating and complex conditions that are often difficult to diagnose and treat. The organisation is dedicated to discover and advance new therapies, providing hope to patients and their families around the world.
Descripción de la oferta
As a Project Manager RA you will be responsible for the submissions and RA strategy of assigned (development) products. You will lead the preparation, writing, review and submission of regulatory documentation and submissions. You will initiate meetings, and discuss submissions, with relevant authorities. It is expected from you to be able to lead and organise others without having direct authority and to perform well under pressure. Furthermore, you will advise and contribute to the planning and development of the global regulatory strategy for assigned products. You are responsible for the development and implementation of the regional regulatory strategy for assigned products and its alignment with the global regulatory strategy. To perform these projects properly, you should be able to explain difficult issues and build consensus within the organisation.
In this position, you will work in a RA team with 4 other members and report directly to the Associate Director Regulatory Affairs Europe. This team is located at Sanofi Genzyme in Naarden (the Netherlands).
Other responsibilities include but are not limited to:
- Act as primary contact point for communication with the regulatory authorities;
- Lead the execution of operational activities relating to the submission process; - Review new information and data related to assigned product(s);
- Review development plans for the assigned product(s) from a regional regulatory perspective and advocate European requirements;
- Work closely with and support departmental and global RA colleagues;
- Contact national or European (EMA) health authorities as appropriate.
Perfil buscado (h/m)
- Master's degree in a relevant area (Life Sciences);
- At least 5 years of relevant work experience in Regulatory Affairs, at a European and/or global level;
- All-round experience in regulatory affairs, i.e. MA maintenance activities as well as regulatory activities of product development (pre-MAA);
- Experience in working with an Orphan Drug is preferred;
- Good planning, project management and collaboration skills;
- Strong communication and negotiation skills;
- Fluent in English (verbal and written).
- Good salary according to knowledge and experience;
- Excellent secondary benefits;
- Good growth and personal development opportunities.