A little about Nordic Pharma:
Nordic Pharma is a mid-size 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 Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Gastroenterology, 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.
Job title : Corporate Regulatory Affairs Manager
Department : Corporate Regulatory Affairs
Reporting to : Corporate Regulatory Affairs Director
Location : Paris 7e arrondissement
General job description :
Corporate Regulatory Affairs Manager for “Genex” projects : Assist the Corporate Regulatory Affairs Director in his various missions and activities and particularly for the registration and maintenance of the product registrations in worldwide territories, to support the Nordic Pharma (Company) business strategy.
Main activities and responsibilities :
➢ Manage the regulatory activities of various products of the company in worldwide territories :
– Coordinate the preparation, submission, and monitoring the MA and medical device files and their maintenance in worldwide territories (variations/changes, safety reports, renewals, answers to questions and requests from supervisory authorities) to ensure there launch and their maintenance in compliance with the local regulation and the company business strategy.
– Manage the above-mentioned coordination as a project leader (identification of resource needed and timelines); – Propose regulatory strategy taking into consideration the local partner feedback, the local regulation and the Company business strategy. – Coordinate the development and the elaboration of the local prescribing information (SmPC, patient leaflet and labeling) for drugs and medical devices, in line with the local regulations and the internal processes.
– Ensure the adequate information are provided to allow the elaboration mock-ups for drugs and medical devices in line with local regulation and the Company business strategy.
– Coordinate the submission and the follow-up of MA and medical device files and their maintenance, in collaboration with local partner, to guarantee the compliance with the local regulation and the Company business strategy.
– Ensure the regular information about the progress of the dossiers under the scope of responsibilities,
– Ensure the provision in due time of the approved prescribing information to the relevant departments,
– Propose and ensure the management of the budget required for the projects under the scope of responsibilities,
– Participate in the regulatory compliance review of the corporate promotional materials (internal documents, website, applications);
➢ Participate in the creation, update, and review of regulatory training, and provide regulatory training for Nordic Pharma employees.
➢ Responsible of the regulatory survey for the product and territories under the scope of the responsibility and in the adequate communication of the information.
➢ Assist the relevant departments and partners on the drug / medical device regulations related to the products under the scope of responsibilities.
➢ Participate in the creation, updating and revision of regulatory standard operating procedures related to the activities under the scope of responsibilities.
➢ Responsible of the data integrity and compliance in the regulatory Database systems for the product / projects under the scope of responsibilities. Responsibilities are:
➢ Propose the regulatory strategy.
➢ Timely submission of regulatory dossiers and their follow-up up to the authority’s decision and implantation in production (when relevant)
➢ Provide response/advice to other departments on regulatory related issues under the supervision of a Corporate Regulatory Affairs Director
➢ Dispatch the adequate Drug MA/ Medical device related information.
➢ Ensure the regulatory intelligence (regulation), assist in the regulatory interpretation, and ensure their adequate dispatch.
➢ Management of RA associate(s)/project manager(s)
➢ Propose and ensure the management of the budget required for the scope of activities.
➢ Guarantee data integrity and data compliance in the regulatory Database systems for the product / projects under the scope of activities.
➢ The contacts established exclusively allow to answer specific questions on the technical / scientific / regulatory level. Lack of promotional activities in its possible contacts with health professionals when contact with health professionals is required
Responsibilities are:
➢ Propose the regulatory strategy.
➢ Timely submission of regulatory dossiers and their follow-up up to the authority’s decision and implantation in production (when relevant)
➢ Provide response/advice to other departments on regulatory related issues under the supervision of a Corporate Regulatory Affairs Director
➢ Dispatch the adequate Drug MA/ Medical device related information.
➢ Ensure the regulatory intelligence (regulation), assist in the regulatory interpretation, and ensure their adequate dispatch.
➢ Management of RA associate(s)/project manager(s)
➢ Propose and ensure the management of the budget required for the scope of activities.
➢ Guarantee data integrity and data compliance in the regulatory Database systems for the product / projects under the scope of activities.
➢ The contacts established exclusively allow to answer specific questions on the technical / scientific / regulatory level. Lack of promotional activities in its possible contacts with health professionals when contact with health professionals is required.
The employee is responsible to comply with Nordic SOPs and guidelines
Essential Competencies :
- Knowledge of (global) RA (relevant regulation/guidelines)
- Management of regulatory affairs for worldwide territories
- Management of the “Genex” team
- Be committed (compliance with timeline and decision taken by the company)
- Be precise and accurate (administrative skills) • Be pro-active
- Good communication skill, including in English language
Qualifications, experience and skills needed :
Qualifications / Education : M.Sc. or Pharmacist diploma. Additional university qualifications in regulatory affairs and/or previous relevant experience in regulatory affairs for worldwide territories are preferable.
Previous Relevant Work Experience / Years of Experience : Minimum of 7-8 years of experience as regulatory affair project manager in an international pharmaceutical environment (preferably US/Japan)
Other Job Requirements : Fluent in English language
Joining us means :
▪ Joining a fast-growing pharmaceutical laboratory and taking part in a dynamic development process;
▪ Choosing to work for a company with strong values, offering a genuine culture of expertise, attractive remuneration and a wide range of benefits (executive status, JRTT, 50% teleworking possible, luncheon vouchers and RIE, employee savings scheme, health insurance, etc.).
We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, so our offers are open to all without restriction.
So don’t wait any longer and join us, by sending your application (CV / covering letter) under reference 2023-CorpRAMan to recrutement@nordicpharma.com
