Vacature Senior Regulatory Affairs Manager - Office-based in Zuid-Holland
Functie: Regulatory Affairs Manager
Regio: Zuid-Holland
Bedrijfomschrijving
The company is one of the top 20 pharmaceutical companies in the world, employing 14,000 people globally. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.
The location in the Netherlands is home to the European R&D organization focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases. An R&D investment budget of 15-20% is evidence of the company's commitment to improving the health of people worldwide through the provision of innovative and reliable products. It is also the head office for the Dutch affiliate.
Functieomschrijving
For the Regulatory Affairs and Quality Assurance department of R&D in the Netherlands, we are looking for a Senior Regulatory Affairs Manager with a focus on development.
In this role you are responsible for the strategic regulatory support throughout the entire development, scientific advice procedures, PIP submissions as well as preparation, submission and defense of registration files (Marketing Authorization Applications) according to current legislation, in order to obtain and maintain marketing authorizations.
Considering the focus on development you will:
- Participate as a Project Team Member, representing Regulatory Affairs in multi-disciplinary development project teams, brand teams and study teams
- Assess registerability of a new product by preparing a Regulatory Development Plan and ensure registerability.
Functie-eisen
The personal qualifications of the Senior Regulatory Affairs Manager:
- Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
- At least 7 years experience with regulatory affairs activities in the pharmaceutical industry and/or with regulatory authorities
- Able to work in a well organized project management result oriented way
- Good communication and writing skills
- Experience with Urology and Pediatric Strategy
- Good knowledge of the regulatory rules, guidances and institutes in the territory
The company offers:
- A challenging and diversified job
- Good career opportunities
- Inspiring work climate
- Attractive remuneration.
Solliciteren
Heb jij interesse in deze functie als Senior Regulatory Affairs Manager voor Zuid-Holland?
Neem dan contact op met Irene Houtsma 
via onderstaande sollicatie knop of bel naar 038-455 62 62..
