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Spécialiste Senior, Affaires Réglementaires

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Poste :                          Spécialiste Senior, Affaires Réglementaires

Relève de  :                  Chef,  Affaires réglementaires

Emplacement :            5485 rue Ferrier, Montréal, QC, H4P 1M6

                                       Télétravail

PORTÉE DE POSITION

Le / la Spécialiste Senior, Affaires réglementaires sera en charge d’effectuer de façon indépendante l’évaluation stratégique pour l’enregistrement et le lancement de médicaments, de produits de santé naturels, de dispositifs médicaux, de cosmétiques et de produits de consommation et de la gestion du processus, jusqu’à la réception finale des autorisations de mise sur le marché et des activités post-commercialisation.

Responsabilités

  • Élaborer des approches pratiques et stratégiques pour les exigences réglementaires, y compris des projets techniques complexes. 
  • Représentation de l’entreprise auprès des autorités réglementaires.
  • Gestion des activités d’intégration pour les acquisitions, y compris le soutien et la transition de la marque, les transferts d’enregistrement et de réglementation.
  • Élaborer des stratégies et gérer les enregistrements et les approbations.
  • Réviser et supporter les études de produits, les études auprès des consommateurs et les études cliniques en lien au développement de produits et/ou pour recueillir/évaluer des données supportant les soumissions.
  • Agir comme liaison entre les affaires réglementaires et d’autres départements au sein de la Société à l’appui des marques, concept de lancement.
  • Évaluer les impacts réglementaires lors de la mise en effet de règlements révisés ou nouveaux, élaborer des stratégies de conformité, communiquer efficacement l’impact aux équipes de gestion appropriées et aux ministères inter fonctionnels.

Qualifications

  • Baccalauréat en sciences
  • Connaissance des lois et règlements canadiens applicables, des lignes directrices et des politiques relatives aux industries pharmaceutiques, des produits de santé naturels et des dispositifs médicaux
  • Professionnel de la réglementation ayant un minimum de 5 ans d’expérience dans une fonction d’affaires réglementaires avec expérience dans l’industrie pharmaceutique ou de dispositifs médicaux
  • Bilingue (parlé et écrit)

Le candidat idéal

  • Excellence dans la résolution de problèmes complexes, l’exécution de projets et les compétences de collaboration.
  • Orienté vers le détail avec excellentes aptitudes analytiques.
  • Capacité de travailler dans un environnement dynamique, de façon autonome et avec un minimum d’aide de la part de son supérieur immédiat
  • Excellente gestion des priorités, compétences de planification et d’organisation
  • Excellente compréhension de la gestion de risques
  • Excellentes compétences en communication pour la présentation aux organismes de réglementation et à l’équipe de gestion
  • Joueur d’équipe, bien articulé et réactif

Position:                          Senior Regulatory Affairs Specialist, Permanent

Reports to:                      Manager, Regulatory Affairs

LOCATION:                      5485 rue Ferrier, Montréal, QC, H4P 1M6

                                          Remote Work

POSITION SCOPE

Independent strategy assessment for registration & launch of drugs, natural health products, medical devices, cosmetics and consumer products and managing through to the final receipt of market authorization and post-market activities.

ESPONSIBILITIES

  • Develop practical and strategical approaches for regulatory requirements, including complex technical projects. 
  • Representing the company with regulatory authorities.
  • Managing integration activities for acquisitions, including brand support and transition, and registration/regulatory transfers.
  • Develop strategies and manage registrations and approvals.
  • Review and support product studies and consumer/clinical studies for product development activity and/or to gather/evaluate data in submission activities.
  • Act as liaison between Regulatory Affairs and other departments within the Company in support of brands, concept to launch.
  • Assess the regulatory impact and implementation of new/proposed regulations, develop compliance strategies, communicate impact effectively to appropriate management teams and cross functional departments.

    QUALIFICATION

  • Bachelor’s degree in Science
  • Knowledge of applicable Canadian Acts and Regulations and Guidelines/Policies as it pertains to the pharmaceutical, natural health product and medical device industries
  • Regulatory professional with 5 years’ experience in a regulatory affairs function with demonstrated capability in a pharmaceutical, OTC, or medical device industry
  • Bilingual (spoken and written)

IDEAL CANDIDATE

  • Excellence in solving complex problems, project execution, and collaboration skills.
  • Detail oriented and excellent analytical skills.
  • Ability to work in fast-paced environment, independently and with accountability & resilience
  • Autonomous and able to set priorities, excellent planning and organization skills.
  • Excellent understanding of Risk Management
  • Excellent communication skills for presenting to regulatory agencies and management team
  • Well organized, articulate, self-starter, responsive and team player

Church and Dwight Canada is an equal opportunity employer committed to providing a barrier-free, inclusive and accessible work environment. Applicants may be entitled to reasonable accommodation in respect of a legally protected characteristic in accordance with applicable human rights legislation. If you require accommodation on this basis, we will work with you to meet your needs. Please inform our Human Resources department if you require an accommodation in completing this application for employment or for otherwise participating in the application process.
 


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Role Location

Canada

Canada is more than its hulking-mountain, craggy-coast good looks: it also cooks extraordinary meals, rocks cool culture and unfurls wild, moose-spotting road trips.

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DIVERSITY At Church & Dwight

Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.

We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.

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CULTURE At Church & Dwight

We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.

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Equal Employment Opportunity for the Disabled At Church & Dwight

As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to jobs@churchdwight.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to jobs@churchdwight.com or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.

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