Do you want to manage the preparation of high quality documentation for all regulatory submissions, following current best practice standards? Read more here!
Reporting to: Associate Director Regulatory Affairs
Location: Heverlee (Belgium) or Amsterdam (Netherlands);
The Regulatory Affairs Manager plans and manages all regulatory activity associated within the business units Belgium, Luxembourg and The Netherlands (Benelux); elegible to act as local responsible for distribution of medicinal products in Norgine NV (Belgium).
Key responsobilities & accountabilities
- Responsible for planning and managing all regulatory activity associated within Benelux
- Manage the Regulatory Affairs team Benelux (currently 4 direct reports)
- Responsible for storage and distribution of all products of Norgine NV (Belgium) in accordance with Good Distribution Practice (GDP). Act as a deputy responsible for GDP for Norgine BV (The Netherlands)
- Responsible for handling complaints, quality defects and recalls for Norgine NV (Belgium)
- Responsible for administrative release of products distributed by Norgine NV (Belgium)
- Is a key member of the Benelux management teams emphasizing the regulatory quality and legal related interests of the business
- Manage the preparation of high quality documentation for all regulatory submissions, following current best practice standards
- Liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met in a compliant manner and proactively communicate with regulatory authorities in Belgium, The Netherlands and Luxembourg in order to expedite approval for submissions
- Manage submission strategy and plans for Belgium, The Netherlands and Luxembourg
- Provide introduction training to new staff
- Support or write applications for pricing and reimbursement
- Manage the regulatory affairs budget of Benelux
- Interact with industry trade associations
Skills & knowledge
- Pharmacist or Physician
- Fluent level of Dutch, French and English language, both verbal as well as written
- Line management experience in a regulatory position (minimum 5 years). Works cooperatively within a team and leads a team as appropriate
- Exercises considerable autonomy in decision making and objective setting
- Excellent interpersonal and leadership skills
- Technical experience of Trackwise, Veeva Vault RIM and SharePoint is a plus
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was EUR 368 million. Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply. Norgine specialises in gastroenterology, hepatology, cancer and supportive care. Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France. For more information, please visit www.norgine.com.
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
Please send your application including motivation letter and resume via the online application form.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.
Acquisition by third parties is not appreciated.
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