Job Description

Notre equipe des affaires reglementaires apporte de nouveaux progres medicaux au monde en simplifiant les communications et les procedures, ce qui permet une conformite rapide et organisee en partenariat avec des organismes de reglementation externes. Nous sommes un reseau a l'avant-garde des soins de sante qui aident a fournir des produits, des pratiques et des solutions medicales nouvelles, fiables et conformes aux exigences mondiales.
Chef de projets, Affaires reglementaires
Le chef de projets, Affaires reglementaires, est responsable de toutes les exigences de soumission clinique du portefeuille de produits auquel il est affecte. Le chef de projets est la personne-ressource concernant les normes gouvernementales aupres des intervenants locaux et du service mondial des Affaires reglementaires. Il collabore efficacement avec les equipes chargees des normes cliniques et les unites de Controle de la fabrication chimique (CFC). Il doit collaborer avec les fournisseurs de composants ainsi qu'avec les autres chefs de projets du service des Affaires reglementaires afin d'assurer l'obtention de resultats de qualite, qui sont fiables du premier coup, dans les delais impartis. Le chef de projets peut aussi participer a d'autres activites et projets et diriger des initiatives d'equipe. Le titulaire de ce poste releve directement du directeur associe, Unite clinique.
Principales responsabilites et activites :
Coordonner la planification, la preparation et le depot des soumissions cliniques aupres de Sante Canada (PDN, SPDN, RPPV, PGR, etc.) pour une liste de produits determinee;
Deposer et assurer le suivi des demandes d'essais cliniques (DEC) aupres de Sante Canada;
Preparer les soumissions normatives et en assurer le suivi aupres de Sante Canada jusqu'a la decision normative finale de Sante Canada. Cela implique d'interagir avec Sante Canada et de servir de personne-ressource principale pour Sante Canada en ce qui concerne les soumissions;
Evaluer, communiquer a la direction locale et mondiale et traiter de facon prioritaire et dans les delais impartis les demandes de Sante Canada (p. ex., evaluation du signal, demandes d'information, acces aux demandes d'information);
Faire en sorte que toutes les activites en lien avec l'homologation de nouveaux produits et leur maintien sur le marche canadien respectent la Loi et le Reglement sur les aliments et drogues, toutes les lignes directrices canadiennes pertinentes, les politiques de Notre entreprise et les modes operatoires normalises (MON) internes et mondiaux;
Agir en tant que liaison entre les partenaires normatifs mondiaux et les equipes interfonctionnelles internes.
Competences :
Diplome universitaire, un B. Sc. ou un diplome plus eleve en science de la sante ou dans un domaine equivalent;
Prefere, mais pas obligatoire : Deux a cinq ans d'experience en normes gouvernementales ou dans un poste connexe au sein d'une societe pharmaceutique ou de biotechnologie;
Connaissance fonctionnelle des normes, directives et politiques de Sante Canada, incluant une connaissance approfondie des exigences normatives de Sante Canada concernant les soumissions cliniques;
Excellentes competences en gestion de temps et organisation et capacite a travailler de facon autonome avec une supervision minimale;
Solides competences en communication (a l'ecrit et a l'oral);
Solides aptitudes de collaboration (esprit d'equipe);
Souci d'obtenir un haut niveau de precision et de qualite dans le travail;
Facilite avec les ordinateurs, maitrise des logiciels de traitement de texte et de presentation et des feuilles de calcul et capacite a apprendre le fonctionnement de nouveaux systemes informatiques;
Competences linguistiques : Francais tant a l'ecrit qu'a l'oral si situe au Quebec. L'anglais requis pour les relations d'affaires avec des intervenants nationaux et internationaux.
Conformement a la Strategie de milieu de travail hybride de notre entreprise, ce poste sera execute au moyen d'une combinaison de travail a distance et de travail en personne (siege social de Kirkland) en fonction de la nature du travail a effectuer.
Nous sommes fiers d'etre une entreprise qui embrasse la valeur de rassembler des personnes diversifiees, talentueuses et engagees. La facon la plus rapide d'innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collegues a remettre en question avec respect les problemes de reflexion et d'approche de l'un et de l'autre. Nous sommes un employeur souscrivant au principe de l'egalite d'acces a l'emploi et nous sommes determines a favoriser un milieu de travail inclusif et diversifie.
Required Skills: Adaptability, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
Secondary Language(s) :
Our regulatory affairs team brings new medical advancements to the world by simplifying communications and procedures, enabling rapid and organized compliance in partnership with external regulatory agencies. We are a network at the forefront of healthcare that helps deliver new, reliable, and compliant medical products, practices, and solutions that meet global requirements.
Project Manager, Regulatory Affairs
The Project Manager, Regulatory Affairs, is responsible for all clinical submission requirements for the product portfolio to which they are assigned. The Project Manager is the resource person regarding government standards for local stakeholders and the global Regulatory Affairs department. They effectively collaborate with teams responsible for clinical standards and Chemical Manufacturing Control (CMC) units. They must work with component suppliers as well as other project managers in the Regulatory Affairs department to ensure quality outcomes that are reliable the first time, within the set deadlines. The Project Manager may also participate in other activities and projects and lead team initiatives. This position reports directly to the Associate Director, Clinical Unit.
Key Responsibilities and Activities:
Coordinate the planning, preparation, and submission of clinical submissions to Health Canada (NDS, SNDS, PSUR, RMP etc.) for a specified list of products.
Submit and follow up on clinical trial applications (CTA) with Health Canada.
Prepare regulatory submissions and follow up with Health Canada until the final regulatory decision is made. This involves interacting with Health Canada and serving as the primary resource person for Health Canada regarding submissions.
Evaluate, communicate to local and global management, and prioritize and address Health Canada requests (e.g., signal assessment, information requests, access to information requests) within the required timelines.
Ensure that all activities related to the approval of new products and their maintenance on the Canadian market comply with the Food and Drugs Act and Regulations, all relevant Canadian guidelines, our company policies, and internal and global standard operating procedures (SOPs).
Act as a liaison between global regulatory partners and internal cross-functional teams.
Skills:
University degree, a B.Sc. or higher in health sciences or a related field.
Preferred, but not required: Two to five years of experience in government standards or a related position within a pharmaceutical or biotechnology company.
Functional knowledge of Health Canada standards, guidelines, and policies, including a thorough understanding of Health Canada's regulatory requirements for clinical submissions.
Excellent time management and organizational skills, with the ability to work independently with minimal supervision.
Strong communication skills (both written and verbal).
Strong collaboration skills (team spirit).
Attention to achieving a high level of accuracy and quality in work.
Proficiency with computers, mastery of word processing, presentation software, and spreadsheets, and the ability to learn how to operate new computer systems.
Language skills: French both written and spoken if located in Quebec. English is also required for business with national and global stakeholders.
In line with our Company's Hybrid Workplace Strategy, this position will be performed through a combination of remote work and in-person (Kirkland Head Office) based on the nature of work to be done.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: No Travel Required
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 10/14/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Skills Required