Vacature Senior Regulatory Operations 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 Operations Manager.
This role is an expert in the field of document management & style compliance, regulatory submissions management & publishing and regulatory information management. Responsibilities will include oversight of submission projects and significant interactions inside and outside the Regulatory Affairs department on complex issues and questions. Provides expertise and leadership in directing projects within assigned areas, including Regulatory Document Management, Submissions Publishing, and/or Regulatory Liaison. The position entails significant interactions with European National Competent Authorities, the European Medicines Agency and Local Affiliates. Serves on increasingly more significant project teams/task forces. Interacts on global projects with other areas of the organization, including colleagues in the US and Japan.
Functie-eisen
Personal qualifications of the Senior Regulatory Operations Manager:
- Academic level of functioning
- At least 5 years relevant experience in the pharmaceutical industry and/or with regulatory authorities,
- Good knowledge of the regulatory processes and principal dossier requirements
- Expert knowledge of document management and electronic publishing systems
- Good communication skills in a multi-cultural working environment
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 Operations Manager voor Zuid-Holland?
Neem dan contact op met Irene Houtsma 
via onderstaande sollicatie knop of bel naar 038-455 62 62..
