Published
22 april 2019
Location
Germany/Europe, Netherlands
Category
 
Job Type
Status
open
Standplaats
Germany or near
Branche
Legal
Opleidingsniveau
Universitair

Description

Our client is a New York-based holding company focused on investments in a rapidly-growing medical product. This dynamic company expands their business globally and they are now ready to enter the European market. With their hub in central Germany and production and distribution facilities in South- and Eastern Europe, they are ready to conquer the European market. As a result of their fast and important business development around the world, they are now looking for a Regional Head of Regulatory Affairs for the European Region.

Head of Regulatory Affairs Europe

As the Regional Head of Regulatory Affairs you are the link between our client and the regulatory authorities in the European region. In a fast expanding company, you will ensure that the (new) products are submitted in accordance with the applicable standards and registration requirements. You analyze the regulatory framework for different products (B2B, pharma, consumer products), create strategies and develop plans to make sure that the products are compliant in relation to the required documentation and legislation for Europe and approved for import, distribution and sales. You know how to efficiently access the right information and to structure content to convey it to the target groups. In this role you will report directly to the CCO.


Responsibilities
• Leading, coordinating, implementing and monitoring registration processes, check and approve qualification files to meet requirements for admission in the specific markets (B2B, pharma and consumer) to ensure that the products comply with the regulations of the regions for distribution;
• Maintains an excellent understanding of the medical cannabis regulations;
• Translating standards and regulations of various countries into requirements for product development, production and document control;
• Develop strong relationships with suppliers, customers and governmental bodies;
• Advise and support clients and project teams about market access requirements, quality and safety standards and regulatory requirements that apply within different countries;
• Maintaining good relations with external Regulatory Affairs authorities, notified bodies and the global network;
• Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same;
• Producing and reviewing SOP’s relating to the Regulatory Affairs function;
• Maintains a system for registration information (license numbers, expiration dates etc) and obtains pre-registration approvals in advance of license expirations to ensure no disruption in product availability.

Qualifications:
• Master degree in science, food engineering or pharmacy;
• 5 years’ experience in a regulated industry in a similar role is desirable;
• Knowledge of EU regulations;
• Fluent in English and preferably German or other European language for daily contact with internal and external partners;
• Good communication and inter-personal skills;
• Proven problem-solving skills;
• High self-motivation

Compensation: Salary levels will be competitive and commensurate with experience and will be coupled with a generous commission and bonus package.

For more information please contact Ms. Elles van der Meer or Mr. Remy Rodenhuis – Nassau Group – Netherlands +31 70 3622005 - www.nassau-group.nl

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