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Regulatory Affairs Specialist/Spécialiste, Affaires Réglementaires

McKesson

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McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we’re so much more than a distribution company. We’ve automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions.

Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all. At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

As the delegate to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Specialist is responsible of performing regulatory activities to maintain the licenses of McKesson Canada and affiliated companies in compliance with the regulations. 

As the delegate to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Specialist is responsible of performing regulatory activities to maintain the licenses of McKesson Canada and affiliated companies in compliance with the regulations. 

Specific Responsibilities

  • Prepare, review and compile high-quality cross licensing submissions for drugs and private label medical devices to ensure they are complete and compliant with applicable guidelines outlined by Health Canada.
  • Review and approve the labels of drugs and private label medical devices prior implementation (signing delegate for Regulatory as required).
  • Initiate change controls related to labels updates and complete their regulatory assessment.
  • Prepare, review and compile Product Monograph updates submissions to Health Canada and contribute to the implementation of a program to manage Product Monographs to ensure that Sivem’s products are compliant to their regulatory filing and safety updates.
  • Prepare, review and compile high-quality provincial formularies submissions to ensure they are complete and compliant with applicable guidelines outlined by the provincial authorities and the private payers.
  • Execute plan to ensure products registration with provincial authorities and private payers is done on time.
  • Investigate and follow up with provincial drug plans to resolve reimbursement issues.
  • Contribute to the development of innovative ways to overcome reimbursement challenges.
  • As delegated by the Senior Manager, Regulatory Affairs, complete regulatory assessment of change controls initiated by other departments.
  • Analyze product information to compile and communicate annual drug notifications and annual renewals of medical devices licenses to Health Canada.
  • Responsible for regulatory activities around renewals and amendments to Drug Establishment Licenses DEL and Medical Devices Establishment Licences MDEL.
  • Provides to our vendors, as requested, the most up-to-date Precursors licenses, Narcotics and Controlled Drugs and Substances licences with related Signing Authority lists, Cannabis drug licenses and other licenses as required.
  • Work with the Senior Manager, Regulatory Affairs on process improvement projects and contribute in the preparation/updates of Standard Operating Procedures (SOPs) and Working Instructions (WI) related to regulatory affairs activities.

Section B – General Responsibilities

  • Maintain department KPI to achieve the business goals.
  • Work closely with the Senior Director Regulatory Affairs to develop a regulatory strategy and answer any regulatory questions raised by the business.
  • Perform other tasks as required delegated by the Senior Manager, Regulatory Affairs or the Senior Director Regulatory Affairs.
  • Act as a backup for Senior Manager, Regulatory Affairs when required.

Requirements

  • Education:

University degree in Science, Health Sciences or Pharmacy, or relevant experience in the pharmaceutical industry.

  • Technical and Soft Skills:
  • 5 years in Regulatory/ Compliance functions including 2 years in regulatory filings in the eCTD format.
  • Knowledge of Health Canada guidance documents related to drug submissions as well as to licensing.
  • Knowledge of the Canadian reimbursement regulations and ability to interpret policies and guidelines. Knowledge of pharmaceutical process manufacturing is an asset.
  • Strong multi-tasking and project management skills,
  • Flexibility and ability to adapt quickly to changing customer needs/demands and environment changes,
  • Well-developed ability to cooperate with others in urgent and complex problem-solving situation,
  • Solid understanding of GMP and Good Documentation Practices in Canada
  • Documentation Management and Quality system management experience 
  • Excellent verbal and written communication and presentation skills,
  • Proficient with Adobe Acrobat and Microsoft Office products, including but not limited to, Windows, Word, Excel, Power Point, Outlook
  • Ability to obtain results with minimal supervision in a team environment,
  • Bilingualism – French/ English (speaking/ writing).

En tant que délégué du chef principal, Affaires réglementaires, le spécialiste en affaires réglementaires est chargé de effectuer des activités reliées à la réglemention afin de maintenir les licences de McKesson Canada et des sociétés affiliées conformément à la réglementation.

Responsabilités Spécifiques

  • Préparer, réviser et compiler les soumissions de licence croisée de haute qualité pour les médicaments et les instruments médicaux de marque privée pour s’assurer qu’elles sont complètes et conformes aux lignes directrices applicables décrites par Santé Canada.
  • Réviser et approuver les étiquettes des médicaments et des instruments médicaux de marque privée avant leur mise en vigueur (délégué des affaires réglementaires pour signature, selon le besoin).
  • Initier les contrôles de changements reliés aux mises à jour des étiquettes et compléter leur évaluation réglementaire.
  • Préparer, reviser et compiler les soumissions de mises à jour des monographies de produit à Santé Canada et contribuer à la mise en place d’un programme de gestion des monographies de produits afin de garantir que les produits de Sivem sont conformes à leur soumission réglementaire et aux mises à jour d’innocuité.
  • Préparer, reviser et compiler des soumissions de haute qualité aux formulaires provinciaux pour s’assurer qu’elles sont complètes et conformes aux lignes directrices applicables énoncées par les autorités provinciales et les payeurs privés.
  • Mettre en œuvre un plan pour s’assurer que l’enregistrement des produits auprès des autorités provinciales et des payeurs privés est effectué à temps.
  • Se renseigner et faire le suivi avec les régimes d’assurance-médicaments provinciaux pour résoudre les problèmes de remboursement.
  • Contribuer au développement de moyens innovateurs pour surmonter les défis de remboursement.
  • Tel que délégué par le gestionnaire, Affaires réglementaires, effectuer une évaluation réglementaire des contrôles de changement initiés par d’autres départements.
  • Analyser les informations sur les produits pour compiler et communiquer les notifications annuelles de médicaments et les renouvellements annuels des homologations d’instruments médicaux à Santé Canada.
  • Responsable des activités réglementaires reliées aux renouvellements et modifications de licences d’établissements de drogues et licences d’établissements d’instruments médicaux.
  • Envoyer aux fournisseurs, tel que demandé, les licences de précurseurs, licences de narcotiques et substances contrôlées avec les signatures autorisées reliées, les licences de drogues contenant du cannabis et d’autres licences tel que requis.
  • Travailler avec le chef principal, Affaires réglementaires sur des projets d’amélioration des processus et contribuer à la préparation / mise à jour des procédures opérationnelles normalisées (SOP) et des instructions de travail (WI) liées aux activités des affaires réglementaires.

Responsabilités Générales

  • Maintenir les indicateurs de performance clés du département pour atteindre les objectifs de l’entreprise.
  • Travailler en étroite collaboration avec le directeur principal des affaires réglementaires pour développer une stratégie réglementaire et répondre à toutes les questions réglementaires soulevées par l’entreprise.
  • Effectuer d’autres tâches, au besoin, déléguées par le gestionnaire des affaires réglementaires ou le directeur principal des affaires réglementaires.
  • Agir à titre de remplaçant pour le chef principal, Affaires réglementaires, au besoin.

– Exigences clés du poste

  • Éducation:

Diplôme universitaire en sciences, sciences de la santé ou pharmacie, ou expérience pertinente dans l’industrie pharmaceutique.

Compétences techniques et générales :

  • 5 ans dans un rôle aux affaires réglementaires / conformité dont 2 ans dans les soumissions réglementaires en format eCTD.
  • Connaissance des documents des lignes directrices de Santé Canada relatifs aux soumissions de médicaments ainsi qu’aux licences.
  • Connaissance de la réglementation canadienne sur le remboursement et capacité d’interpréter les politiques et les lignes directrices. La connaissance de la fabrication de procédés pharmaceutiques est un atout.
  • Solides compétences multitâches et gestion de projets,
  • Flexibilité et capacité à s’adapter rapidement aux changements des besoins / demandes des clients et aux changements dans l’environnement de travail.
  • Capacité bien développée à coopérer avec les autres dans des situations de résolution de problèmes urgentes et complexes.
  • Bonne compréhension des BPF et des bonnes pratiques de documentation au Canada.
  • Expérience en gestion de la documentation et en système de gestion de la qualité.
  • Excellentes compétences en communication verbale et écrite et en présentation,
  • Maîtrise d’Adobe Acrobat et des produits de Miscrosoft, y compris mais sans s’y limiter à, Windows, Word, Excel, Power Point, Outlook.
  • Capacité à obtenir des résultats avec un minimum de supervision dans un environnement d’équipe,
  • Bilinguisme – français / anglais (parlé / écrit).

Career Level – IC – Professional – P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. 

Our Base Pay Range for this position

$66,400 – $110,600

McKesson is an Equal Opportunity employer.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.

The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.

McKesson is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants’ needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.

The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

Current employees must apply through internal career site.

Join us at McKesson!

Read Full Description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we’re so much more than a distribution company. We’ve automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions.

Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all. At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

As the delegate to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Specialist is responsible of performing regulatory activities to maintain the licenses of McKesson Canada and affiliated companies in compliance with the regulations. 

As the delegate to the Senior Manager, Regulatory Affairs, the Regulatory Affairs Specialist is responsible of performing regulatory activities to maintain the licenses of McKesson Canada and affiliated companies in compliance with the regulations. 

Specific Responsibilities

  • Prepare, review and compile high-quality cross licensing submissions for drugs and private label medical devices to ensure they are complete and compliant with applicable guidelines outlined by Health Canada.
  • Review and approve the labels of drugs and private label medical devices prior implementation (signing delegate for Regulatory as required).
  • Initiate change controls related to labels updates and complete their regulatory assessment.
  • Prepare, review and compile Product Monograph updates submissions to Health Canada and contribute to the implementation of a program to manage Product Monographs to ensure that Sivem’s products are compliant to their regulatory filing and safety updates.
  • Prepare, review and compile high-quality provincial formularies submissions to ensure they are complete and compliant with applicable guidelines outlined by the provincial authorities and the private payers.
  • Execute plan to ensure products registration with provincial authorities and private payers is done on time.
  • Investigate and follow up with provincial drug plans to resolve reimbursement issues.
  • Contribute to the development of innovative ways to overcome reimbursement challenges.
  • As delegated by the Senior Manager, Regulatory Affairs, complete regulatory assessment of change controls initiated by other departments.
  • Analyze product information to compile and communicate annual drug notifications and annual renewals of medical devices licenses to Health Canada.
  • Responsible for regulatory activities around renewals and amendments to Drug Establishment Licenses DEL and Medical Devices Establishment Licences MDEL.
  • Provides to our vendors, as requested, the most up-to-date Precursors licenses, Narcotics and Controlled Drugs and Substances licences with related Signing Authority lists, Cannabis drug licenses and other licenses as required.
  • Work with the Senior Manager, Regulatory Affairs on process improvement projects and contribute in the preparation/updates of Standard Operating Procedures (SOPs) and Working Instructions (WI) related to regulatory affairs activities.

Section B – General Responsibilities

  • Maintain department KPI to achieve the business goals.
  • Work closely with the Senior Director Regulatory Affairs to develop a regulatory strategy and answer any regulatory questions raised by the business.
  • Perform other tasks as required delegated by the Senior Manager, Regulatory Affairs or the Senior Director Regulatory Affairs.
  • Act as a backup for Senior Manager, Regulatory Affairs when required.

Requirements

  • Education:

University degree in Science, Health Sciences or Pharmacy, or relevant experience in the pharmaceutical industry.

  • Technical and Soft Skills:
  • 5 years in Regulatory/ Compliance functions including 2 years in regulatory filings in the eCTD format.
  • Knowledge of Health Canada guidance documents related to drug submissions as well as to licensing.
  • Knowledge of the Canadian reimbursement regulations and ability to interpret policies and guidelines. Knowledge of pharmaceutical process manufacturing is an asset.
  • Strong multi-tasking and project management skills,
  • Flexibility and ability to adapt quickly to changing customer needs/demands and environment changes,
  • Well-developed ability to cooperate with others in urgent and complex problem-solving situation,
  • Solid understanding of GMP and Good Documentation Practices in Canada
  • Documentation Management and Quality system management experience 
  • Excellent verbal and written communication and presentation skills,
  • Proficient with Adobe Acrobat and Microsoft Office products, including but not limited to, Windows, Word, Excel, Power Point, Outlook
  • Ability to obtain results with minimal supervision in a team environment,
  • Bilingualism – French/ English (speaking/ writing).

En tant que délégué du chef principal, Affaires réglementaires, le spécialiste en affaires réglementaires est chargé de effectuer des activités reliées à la réglemention afin de maintenir les licences de McKesson Canada et des sociétés affiliées conformément à la réglementation.

Responsabilités Spécifiques

  • Préparer, réviser et compiler les soumissions de licence croisée de haute qualité pour les médicaments et les instruments médicaux de marque privée pour s’assurer qu’elles sont complètes et conformes aux lignes directrices applicables décrites par Santé Canada.
  • Réviser et approuver les étiquettes des médicaments et des instruments médicaux de marque privée avant leur mise en vigueur (délégué des affaires réglementaires pour signature, selon le besoin).
  • Initier les contrôles de changements reliés aux mises à jour des étiquettes et compléter leur évaluation réglementaire.
  • Préparer, reviser et compiler les soumissions de mises à jour des monographies de produit à Santé Canada et contribuer à la mise en place d’un programme de gestion des monographies de produits afin de garantir que les produits de Sivem sont conformes à leur soumission réglementaire et aux mises à jour d’innocuité.
  • Préparer, reviser et compiler des soumissions de haute qualité aux formulaires provinciaux pour s’assurer qu’elles sont complètes et conformes aux lignes directrices applicables énoncées par les autorités provinciales et les payeurs privés.
  • Mettre en œuvre un plan pour s’assurer que l’enregistrement des produits auprès des autorités provinciales et des payeurs privés est effectué à temps.
  • Se renseigner et faire le suivi avec les régimes d’assurance-médicaments provinciaux pour résoudre les problèmes de remboursement.
  • Contribuer au développement de moyens innovateurs pour surmonter les défis de remboursement.
  • Tel que délégué par le gestionnaire, Affaires réglementaires, effectuer une évaluation réglementaire des contrôles de changement initiés par d’autres départements.
  • Analyser les informations sur les produits pour compiler et communiquer les notifications annuelles de médicaments et les renouvellements annuels des homologations d’instruments médicaux à Santé Canada.
  • Responsable des activités réglementaires reliées aux renouvellements et modifications de licences d’établissements de drogues et licences d’établissements d’instruments médicaux.
  • Envoyer aux fournisseurs, tel que demandé, les licences de précurseurs, licences de narcotiques et substances contrôlées avec les signatures autorisées reliées, les licences de drogues contenant du cannabis et d’autres licences tel que requis.
  • Travailler avec le chef principal, Affaires réglementaires sur des projets d’amélioration des processus et contribuer à la préparation / mise à jour des procédures opérationnelles normalisées (SOP) et des instructions de travail (WI) liées aux activités des affaires réglementaires.

Responsabilités Générales

  • Maintenir les indicateurs de performance clés du département pour atteindre les objectifs de l’entreprise.
  • Travailler en étroite collaboration avec le directeur principal des affaires réglementaires pour développer une stratégie réglementaire et répondre à toutes les questions réglementaires soulevées par l’entreprise.
  • Effectuer d’autres tâches, au besoin, déléguées par le gestionnaire des affaires réglementaires ou le directeur principal des affaires réglementaires.
  • Agir à titre de remplaçant pour le chef principal, Affaires réglementaires, au besoin.

– Exigences clés du poste

  • Éducation:

Diplôme universitaire en sciences, sciences de la santé ou pharmacie, ou expérience pertinente dans l’industrie pharmaceutique.

Compétences techniques et générales :

  • 5 ans dans un rôle aux affaires réglementaires / conformité dont 2 ans dans les soumissions réglementaires en format eCTD.
  • Connaissance des documents des lignes directrices de Santé Canada relatifs aux soumissions de médicaments ainsi qu’aux licences.
  • Connaissance de la réglementation canadienne sur le remboursement et capacité d’interpréter les politiques et les lignes directrices. La connaissance de la fabrication de procédés pharmaceutiques est un atout.
  • Solides compétences multitâches et gestion de projets,
  • Flexibilité et capacité à s’adapter rapidement aux changements des besoins / demandes des clients et aux changements dans l’environnement de travail.
  • Capacité bien développée à coopérer avec les autres dans des situations de résolution de problèmes urgentes et complexes.
  • Bonne compréhension des BPF et des bonnes pratiques de documentation au Canada.
  • Expérience en gestion de la documentation et en système de gestion de la qualité.
  • Excellentes compétences en communication verbale et écrite et en présentation,
  • Maîtrise d’Adobe Acrobat et des produits de Miscrosoft, y compris mais sans s’y limiter à, Windows, Word, Excel, Power Point, Outlook.
  • Capacité à obtenir des résultats avec un minimum de supervision dans un environnement d’équipe,
  • Bilinguisme – français / anglais (parlé / écrit).

Career Level – IC – Professional – P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. 

Our Base Pay Range for this position

$66,400 – $110,600

McKesson is an Equal Opportunity employer.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.

The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.

McKesson is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants’ needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.

The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

Current employees must apply through internal career site.

Join us at McKesson!

Read Full Description

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