RESPONSABILITÉS

Le spécialiste est responsable de l’exécution des activités relatives aux Affaires Réglementaires.
Il se rapporte au Directeur adjoint aux Affaires Réglementaires.

Ses principales responsabilités sont les suivantes:

• Préparation de soumissions auprès des autorités fédérales (supplément à une présentation de drogue nouvelle (PDN), préavis de modification, renouvellement de DIN) et de documents de réglementation pour des changements de Niveau III et de Niveau IV pour une liste de projets donnée.
• Soutenir les activités réglementaires liées au maintien des Licences d’Établissement (LEPP/LEIM) et peut être chargé de la préparation des demandes ou des modifications.
• Coordonner et exécuter les demandes du Programme d’Accès Spécial (selon le cas, en fonction de l’affectation).
• Coordonner et répondre aux demandes d’Accès à l’Information (ATI), y compris les relations avec les membres de l’équipe locale et mondiale (selon le cas, en fonction de l’affectation).
• Assurer l’archivage des données et de la documentation réglementaires conformément aux politiques du service et de l’entreprise, et aux exigences locales.
• Peut être affecté à des tâches pour soutenir les activités de surveillance de la conformité du service.
• Peut participer aux activités de soutien du service des Affaires réglementaires, s’il y a lieu, y compris la préparation des documents réglementaires, la tenue à jour des outils et des bases de données de suivi, et d’autres activités ou projets.
• Le titulaire du poste doit remplir ses fonctions en toute conformité avec l’engagement de la société envers ses valeurs, ses normes, ses politiques et ses procédures ainsi qu’avec les normes de l’industrie et toutes les lois et tous les règlements applicables.

REQUIRED EDUCATION, EXPERIENCE, AND SKILLS

• Health or life science university degree or equivalent by education / experience. DESS or M. Sc. in Drug Development/Regulatory Affairs is an asset.Collaboration and Partnering: Demonstrates ability to work in partnership with others (internally and externally) to accomplish quality goals.
• Communication Skills: Demonstrates good communications skills to convey and receive information in English and in French.
• Project Management: Demonstrates good skills in the ability to organize work efforts, prioritize tasks and utilize appropriate resources to support activities in accordance with timelines and appropriate regulations.
• Attention to detail: High level of accuracy & quality in work
• General knowledge of Health Canada regulations, guidance and policies, and an understanding of regulatory affairs organization, processes and compliance expectations.
• Prior industry experience in regulatory affairs

WHO WE ARE:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

The Specialist is responsible for executing activities related to regulatory affairs.
The position reports to the Associate Director, Regulatory Affairs.

The main responsibilities include:

• Preparation of federal regulatory submissions (SNDSs, NCs, DIN submissions) and regulatory documents supporting Level III notifications and Level IV record of changes for an assigned list of projects.
• Support regulatory activities related to the maintenance of Establishment Licenses (DEL/MDEL) and may be assigned to preparation of applications or amendments
• Coordinates Certificate of Pharmaceutical Product (CPP) requests supporting registrations in foreign countries (as applicable, based on assignment).
• Coordinates and executes Special Access Program requests (as applicable, based on assignment).
• Coordinates and responds to Access to Information requests (ATIs), including liaison with local and global team members (as applicable, based on assignment).
• Ensures archival of regulatory data and documentation in accordance with department and company policies and local requirements.
• May be assigned to tasks supporting compliance oversight activities of the department.
• May undertake additional activities to support the RA department, including preparation of regulatory documents, maintenance of tracking tools/databases or other activities or projects
• The incumbent will complete his/her tasks in a manner fully consistent with the company’s commitment to its values and standards, policies, procedures, industry standards and all laws and regulations.