Job Description Responsabilits Le spcialiste est responsable de lexcution des activits relatives aux Affaires Rglementaires.

Il se rapporte au Directeur adjoint aux Affaires Rglementaires.

Ses principales responsabilits sont les suivantes: Prparation de soumissions auprs des autorits fdrales (supplment une prsentation de drogue nouvelle (PDN), pravis de modification, renouvellement de DIN) et de documents de rglementation pour des changements de Niveau III et de Niveau IV pour une liste de projets donne.

Interaction avec Sant Canada (SC) concernant les soumissions rglementaires et le suivi jusqu'' la dcision rglementaire finale de Sant Canada.

Soutenir les activits rglementaires lies au maintien des Licences d''tablissement (LEPP/LEIM) et peut tre charg de la prparation des demandes ou des modifications.

Coordonne les demandes de Certificat de Produit Pharmaceutique (CPP) soutenant les enregistrements dans les pays trangers (le cas chant, en fonction de la mission).

Assurer larchivage des donnes et de la documentation rglementaires conformment aux politiques du service et de lentreprise, et aux exigences locales.

Peut tre affect des tches pour soutenir les activits de surveillance de la conformit du service.

Peut participer aux activits de soutien du service des Affaires rglementaires, sil y a lieu, y compris la prparation des documents rglementaires, la tenue jour des outils et des bases de donnes de suivi, et dautres activits ou projets.

Le titulaire du poste doit remplir ses fonctions en toute conformit avec lengagement de la socit envers ses valeurs, ses normes, ses politiques et ses procdures ainsi quavec les normes de lindustrie et toutes les lois et tous les rglements applicables. ducation, Exprience et Comptences Requises Les principales comptences incluent, entre autres: Collaboration et partenariat: Capacit travailler en partenariat avec dautres ( linterne et lexterne) pour atteindre des objectifs de qualit.

Aptitudes en communication: Bonnes aptitudes de communication pour transmettre et recevoir de linformation en anglais et en franais.

Gestion de projets: Bonnes aptitudes organiser le travail, tablir lordre de priorit des tches et utiliser les ressources appropries pour mener bien les activits conformment aux chanciers et aux rglements appropris.

Souci du dtail: Minutie et qualit du travail.

Exprience et Qualifications:



Diplme universitaire en sciences de la vie ou en sciences de la sant, ou lquivalent selon la formation ou lexprience.

Le Diplme dtudes suprieures spcialises ou matrise en dveloppement du mdicament / Affaires Rglementaires est un atout.

Connaissance gnrale des rglements, lignes directrices et politiques de Sant Canada, et comprhension des attentes de lentreprise sur le plan des affaires rglementaires, des processus et de la conformit.

Exprience pralable dans le domaine des Affaires Rglementaires.

Secondary Job Description Responsibilities 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.

Interaction with Health Canada (HC) with regards to regulatory submissions and following-up until final Health Canada regulatory decision.

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).

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 companys commitment to its values and standards, policies, procedures,



industry standards and all laws and regulations.

Required Education, Experience, and Skills Primary skills include but are not limited to: 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 Experience and Qualifications Health or life science university degree or equivalent by education / experience. DESS or M.

Sc. in Drug Development/Regulatory Affairs is an asset.

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 Womens 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 prospect employer, we welcome applications from candidates with a diverse background.

We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Regular Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

📌 Spécialiste, Affaires Réglementaires | Specialist, Regulatory Affairs (Kirkland)
🏢 organón
📍 Kirkland