Nordic Pharma is a privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma’s expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Women’s Health and Critical care (Anaesthesia, Haematology, Oncology).
Nordic Pharma’s values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working.
GENERAL SUMMARY OF ROLE:
The Corporate Regulatory Affairs Department (an international team of 7 employees based in France and in the Netherlands) oversees a portfolio of 188 drug marketing authorizations for products registered in more than 28 countries via all types of Procedures (centralized, MRP, DCP and international procedures). To support our projects, we are recruiting a Regulatory Affairs Associate.
The Regulatory Affairs Associate will work in close cooperation with a Manager to support the activities required for the maintenance, renewal and management of these marketing authorizations. This opportunity would suit to a candidate university graduated in pharmaceutical or medical science, fluent in English, having rigorous skills and with a strong appetence in solving issues. This full time position is already opened and will be based in The Netherlands (Amsterdam area).
ESSENTIAL RESPONSIBILITIES AND TASKS:
Under the supervision of a Regulatory Affairs Manager in charge of several therapeutic areas, you will ensure the following actions for several marketing authorizations (MA) registered in Centralised Procedure, Decentralised Procedure and National Procedures:
Preparation of content, eTCD sequences publishing, submission, monitoring of MA related dossiers and maintenance of these dossiers for EU and outside EU (variations, PSURs, renewals, answers to questions and requests from supervisory authorities) in order to ensure compliance with regulatory expectations and strategy defined by the company,
Management of regulatory change control,
Compilation of the IMPD for clinical studies’ dossiers,
Update of the common annexes (SmPC, patient leaflet and labelling) and the corresponding mock-ups of drugs and medical devices and their adequate dispatch,
Check the compliance of corporate promotional materials (internal documents, website…),
Participate in the creation, update and reviewal of regulatory training,
Participate in the European regulatory intelligence for health products (drugs, medical devices and in vitro diagnostic medical devices),
Participate in the creation, update and revision of regulatory standard operating procedures.