Director, Regulatory Affairs Canada
Jazz Pharmaceuticals —Mississauga, ON
- $180,000–$270,000 a year
- Marketing
- English
- Master's degree
- Disability insurance
- Dental care
3d
Gestionnaire bilingue des communications, SCFC / Communications Manager, FCC Bilingual
Fidelity Investments —Toronto, ON
- $105,000–$123,000 a year
- Full-time
- Hybrid work
- Bilingual
- English
- Bachelor's
- Tuition reimbursement
- Paid time off
8d
Occupational Health & Safety Manager
Gateway Casinos Corporate Office —Etobicoke, ON
- $105,074 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
National Clinical Service Specialist (BC, ON, QC)
BD —Mississauga, ON
- $85,000–$135,000 a year
- Bilingual
- Nursing
- English
Senior Specialist, Quality Assurance
Shoppers Drug Mart / Pharmaprix —Toronto, ON
- $68,000–$93,500 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
9d
Paralegal
AIG Insurance Company of Canada —Toronto, ON
- $64,000–$80,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Writing skills
Quick apply
Manager and Interprofessional Practice Chief - Nursing
Baycrest —Toronto, ON
- $121,139–$151,424 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Marketing Manager
Kohl & Frisch Limited —Toronto, ON
- $100,000–$130,000 a year
- Marketing
- Bachelor's
- Business
- Dental care
- Employee assistance program
10d
AP & AR Coordinator
Royal College of Dental Surgeons of Ontario —Toronto, ON
- $58,640.00–$65,970.90 a year
- Full-time
- Bilingual
- Microsoft Word
- Microsoft Excel
Quick apply
9d
Marketing Manager
Kohl & Frisch Ltd —Concord, ON
- $100,000–$130,000 a year
- Marketing
- Bachelor's
- Business
- Dental care
- Employee assistance program
Quick apply
12d
Legal & Corporate Affairs Coordinator- Relocate to Port Hardy, BC
K'awat'si Economic Development Corporation —Canada
- $55,000–$65,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Wellness program
- Relocation assistance
Quick apply
14d

More jobs to discover

Find similar jobs that you might be interested in.

Registered Products Administrator
Fidelity Investments —Toronto, ON
Completion of, or enrolment in, a financial services industry program (e.g. CSC). The Registered Products team is responsible for settlements with our Trustee,…
$26–$30 an hour
9d

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Director, Redevelopment
Southlake Health —Newmarket, ON
Provide strategic leadership for the planning, design, development, procurement and implementation of Southlake’s redevelopment project.
$84.67–$100.64 an hour
Manager and Interprofessional Practice Chief - Nursing
Baycrest —Toronto, ON
Represents the professional discipline on corporate, regional, provincial and national profession-specific committees/ networks and leads the development and…
$121,139–$151,424 a year

I want to receive the latest job alerts for director of regulatory affairs in toronto, on

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

director of regulatory affairs jobs near toronto, on

Director Of Regulatory Affairs jobs in Mississauga, ON

Clinical Specialist jobs in Mississauga, ON

Marketing Manager jobs in Toronto, ON

Accounts Payable Accounts Receivable Clerk jobs in Toronto, ON

Paralegal jobs in Toronto, ON

Practice Nurse jobs in Toronto, ON

Food Regulatory jobs in Ontario

Director Of Regulatory Affairs jobs in Montréal, Qc

Director jobs in Victoria, Bc

Director Of Regulatory Affairs jobs in Toronto, On

Director Of Regulatory Affairs jobs in Vancouver, Bc

Director Of Collections jobs in Toronto, On

Responsable Communication jobs in Lasalle, Qc

Communication jobs in Montréal, Qc

Environmental Communication jobs in Ontario

Science Communication Remote jobs in Toronto, On

Communication Communication jobs in Nanaimo, Bc

Responsable Communication jobs in Province De Québec

Responsable Communication jobs in Brossard, Qc

Responsable Communication jobs in Montréal, Qc

Director, Regulatory Affairs Canada

Jazz Pharmaceuticals -
Mississauga, ON

Apply Now

Job details

$180,000–$270,000 a year
3 days ago

Qualifications

Marketing
English
Master's degree
Bachelor's
Negotiation

Full job description

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.

Apply Now

Refine Your Search

director of regulatory affairs jobs in toronto, on

Director, Regulatory Affairs Canada

Gestionnaire bilingue des communications, SCFC / Communications Manager, FCC Bilingual

Occupational Health & Safety Manager

National Clinical Service Specialist (BC, ON, QC)

Senior Specialist, Quality Assurance

Paralegal

Manager and Interprofessional Practice Chief - Nursing

Marketing Manager

AP & AR Coordinator

Marketing Manager

Legal & Corporate Affairs Coordinator- Relocate to Port Hardy, BC

More jobs to discover

Explore jobs in cities nearby

I want to receive the latest job alerts for director of regulatory affairs in toronto, on

Related Searches

Explore jobs in more locations

Principal Duties and Responsibilities:

Required Knowledge, Skills, and Abilities

Required/Preferred Education and Licenses

Job seeker tools

Employer Tools

Browse

Stay Connected