Director, Regulatory Affairs Canada
Jazz Pharmaceuticals —Mississauga, ON
- De 180 000 $ à 270 000 $ par an
- Marketing
- Anglais
- Maîtrise
- Assurance Invalidité
- Assurance Dentaire
Product Compliance & Regulatory Affairs Specialist
Frontier Dental Supply —Markham, ON
- De 75 000 $ à 80 000 $ par an
- Temps plein
- Ingénierie
- Bases de données
- Baccalauréat
- Assurance Dentaire
- Bourses d'Études
Regulatory Affairs Associate
CanPrev Natural Health Products Ltd. —North York, ON
- De 55 000 $ à 60 000 $ par an
- Temps plein
- Travail hybride
- Bilingue
- Compétences rédactionnelles
- Anglais
- Réductions Tarifaires
- Assurance Dentaire
Postuler rapidement
Regulatory Affairs Associate — Canada
Ryvis Pharma —Mississauga, ON
- Temps plein
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Communications Advisor
Registered Insurance Brokers of Ontario (RIBO) —Toronto, ON
- De 56 000 $ à 62 000 $ par an
- Temps plein
- Travail hybride
- Marketing
- Compétences rédactionnelles
- Microsoft Office
- Assurance Dentaire
- Congés payés
Postuler rapidement
il y a 10 jours
Senior Manager, Regulatory Affairs - Product Safety & Toxicology - Global
DECIEM —Toronto, ON
- De 110 000 $ à 120 000 $ par an
- Temps plein
- Travail hybride
- Gestion de projet
- Leadership
- Compétences en communication
- Congés payés
- Programme d'Aide aux Employés
il y a 1 jour
Regulatory Affairs Coordinator
CPG Executive Search —Brampton, ON
- De 50 000 $ à 70 000 $ par an
- Temps plein
- Bilingue
- Microsoft Word
- Microsoft Excel
- Assurance Dentaire
- Congés payés
Postuler rapidement
Associate Director - Molecular Testing/Genomics
Canadian Blood Services —Brampton, ON
- De 132 300 $ à 155 600 $ par an
- Temps plein
- Travail hybride
- Médecine
- Expérience en gestion
- Doctorat
- Programmes de Bien-être
- Assurance Dentaire
il y a 8 jours
Manufacturing Quality Assurance Associate - AM Shift Contract
DECIEM —Etobicoke, ON
- De 45 000 $ à 50 000 $ par an
- Contrat
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Congés payés
- Programme d'Aide aux Employés
Regulatory Affairs Manager
Haleon —Mississauga, ON
- De 100 000 $ à 120 000 $ par an
- Temps plein
- Travail hybride
- Doctorat
- Maîtrise
- Affaires
- Congés payés
Regulatory Affairs Specialist
Brenntag Canada Inc. —Mississauga, ON
- Temps plein
- Anglais
- Affaires
- Compétences en communication
- Assurance Dentaire
- Bourses d'Études
Postuler rapidement
il y a 4 jours
Manager- Quality Assurance Regulatory Affairs Mississauga, ON
Globyz —Mississauga, ON
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quality Assurance Regulatory Specifications Specialist
Metro —Etobicoke, ON
- De 54 480 $ à 71 505 $ par an
- Travail hybride
- Bilingue
- Microsoft Excel
- Anglais
- Programme d'Aide aux Employés
- Heures d'arrivée et de départ flexibles
Medical Writer (Medical Affairs)
Red Nucleus —Toronto, ON
- De 85 000 $ à 100 000 $ par an
- Temps plein
- Médecine
- Doctorat
- Compétences rédactionnelles
Professor, Part-Time (Pharmaceutical Regulatory Affairs & Quality Operations)
Seneca Polytechnic —North York, ON
- Temps partiel
- Maîtrise
- Expérience administrative
- Diplôme d'études secondaires
Head, Regulatory Affairs, General Medicine and Vaccines Canada
Sanofi —Toronto, ON
- De 125 300,00 $ à 180 966,66 $ par an
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Programmes de Bien-être
National Director Contract Logistics Quality & Regulatory Affairs
Kuehne+Nagel —Mississauga, ON
- De 120 934 $ à 151 167 $ par an
- Travail hybride
- Leadership
- Assurance Dentaire
- Bourses d'Études
Senior Regulatory Operations Specialist
Cencora —Toronto, ON
- De 67 000 $ à 102 960 $ par an
- Temps plein
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Assurance Dentaire
- Congés payés
Principal, Medical Affairs
Acumetis —Toronto, ON
- De 250 000 $ à 300 000 $ par an
- Travail hybride
- Médecine
- Doctorat
- Maîtrise
Quality Assurance and Regulatory Affairs Associate - Entry Level
BTNX Inc. —Markham, ON
- De 40 000 $ à 45 000 $ par an
- Temps plein
- Maîtrise
- Baccalauréat
- Restaurant rapide
- Assurance Invalidité
- Assurance Dentaire

Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : regulatory affairs (toronto, on)

En vous connectant à votre compte, vous acceptez les conditions d'utilisation, la politique relative aux fichiers témoins et la politique de confidentialité de SimplyHired.

Director, Regulatory Affairs Canada

Jazz Pharmaceuticals -
Mississauga, ON

Postuler dès maintenant

Détails du poste

De 180 000 $ à 270 000 $ par an

Profil recherché

Marketing
Anglais
Maîtrise
Baccalauréat
Négociation

Description complète du poste

The Director, Regulatory Affairs, Canada, is a member of the Global Regulatory Affairs and Drug Safety (GRADS) team and is responsible for providing strategic regulatory direction for designated projects, ensuring that the latest Health Canada requirements and standards are met. The individual will interface with Health Canada and business partners regarding development, regulatory and registration strategies. With a solid reporting line into Global Regulatory Affairs (Regulatory Strategy), the individual will also be a member of the extended Canadian leadership team.

Principal Duties and Responsibilities:

Canadian Regulatory Lead - Function as a leader in Jazz GRADS and Canada’s extended leadership team and serve as Regulatory Responsible Person.

Act as local regulatory point of contact for the product collaborating with Global Regulatory Lead (GRL) / Global Regulatory Team (GRT):

Provides, as subject matter expert, strategic and operational regulatory input (including Health Authority Insights) on projects including, but not limited to, Canadian regulatory strategies, regulatory requirements for clinical studies, marketing approval and post-approval activities in Canada, regulatory strategic development plans and risk assessments, critical issue management and advice on Regulatory Interactions with Health Canada.
In partnership with the Global Regulatory Lead (GRL) and other technical experts, liaises and negotiates with Health Canada, as needed, pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labelling, with clear documentation of discussion and agreements, as directed by line management.
Maintains awareness of the global regulatory environment and assesses the impact of changes on business and product development programs.
Builds partnerships with key peers and senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
Responsible for assisting with the development, implementation and enforcement of regulatory processes.
Support global regulatory in product submissions, market authorization, and label updates in collaboration with Regulatory Strategy, Global Product Labelling and INSPIRE teams, as applicable
Support product expansion activities in international markets, such as Middle East, North Africa, Latin America and Asia Pacific markets, as applicable.
Support Health Canada inspections as Regulatory Strategy point person

Required Knowledge, Skills, and Abilities

Previous experience of Responsible Person responsibilities in a corporate setting.
Previous experience of undertaking regulatory submissions, ideally in a corporate pharmaceutical environment.
Progressive experience within the pharmaceutical industry including Regulatory Affairs.
Deep knowledge of business and market dynamics.
Strong knowledge of the local legislation in the pharmaceutical market as well as of SOPs, policies and procedures.
Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
Regulatory experience with CTAs, NDSs, lifecycle management, interactions with Regulatory Agencies, and developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
Able to understand and optimize internal processes.
Technical competencies on regulatory and governance linked to the Canadian market and organization
Proven interpersonal skills with the ability to work collaboratively and flexibly as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
Problem solving; strong negotiating skills and ability to think creatively and develop creative solutions.
Excellent command of English; excellent verbal and written skills. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.

Required/Preferred Education and Licenses

Bachelor’s degree: Masters or other advanced degree preferred.

#LI-SM1

#LI-remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR CANADA BASED CANDIDATES ONLY

Jazz Pharmaceuticals Canada, Inc. and Celator Pharmaceuticals Corp. are committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.

For this role, the full and complete base pay range is: $180,000.00 - $270,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual pay decisions. This range will be reviewed on a regular basis.

At Jazz/Celator, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, Extended Health Care, Dental, Long Term Disability, Life Insurance, RRSP, and paid vacation.

Postuler dès maintenant

Affinez votre recherche

regulatory affairs emplois - toronto, on

Director, Regulatory Affairs Canada

Product Compliance & Regulatory Affairs Specialist

Regulatory Affairs Associate

Regulatory Affairs Associate — Canada

Communications Advisor

Senior Manager, Regulatory Affairs - Product Safety & Toxicology - Global

Regulatory Affairs Coordinator

Associate Director - Molecular Testing/Genomics

Manufacturing Quality Assurance Associate - AM Shift Contract

Regulatory Affairs Manager

Regulatory Affairs Specialist

Manager- Quality Assurance Regulatory Affairs Mississauga, ON

Quality Assurance Regulatory Specifications Specialist

Medical Writer (Medical Affairs)

Professor, Part-Time (Pharmaceutical Regulatory Affairs & Quality Operations)

Head, Regulatory Affairs, General Medicine and Vaccines Canada

National Director Contract Logistics Quality & Regulatory Affairs

Senior Regulatory Operations Specialist

Principal, Medical Affairs

Quality Assurance and Regulatory Affairs Associate - Entry Level

Je souhaite recevoir la dernière alerte emploi pour les postes de ce type : regulatory affairs (toronto, on)

Related Searches

Principal Duties and Responsibilities:

Required Knowledge, Skills, and Abilities

Required/Preferred Education and Licenses

Outils pour les chercheurs d'emploi

Outils Employeurs

Parcourir

Garder le contact