25 Best regulatory affairs manager jobs in mississauga, on (Hiring Now!)

Regulatory Affairs Manager
Confidential —Etobicoke, ON
The Regulatory Affairs Manager is responsible for developing the regulatory strategy of both products approved and products under development, defining…
Quick apply
7d
Labelling & Change Management Specialist (Contract 18-Months)
Fresenius Kabi Canada —Toronto, ON
You have a Bachelor of Science degree in a life science (chemistry and/or microbiology preferred), some laboratory experience, prior experience in the…
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4h
Regulatory Affairs Coordinator (On-Site for Bolton, ON)
Agrocrop Exports Ltd. —Caledon, ON
Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and…
$55,000–$60,000 a year
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13h
Testing Support Associate, Molecular Testing
Canadian Blood Services —Brampton, ON
Leveraging your collaborative and communication skills, you will liaise with other Canadian Blood Services departments (Quality Assurance and Regulatory Affairs…
$78,895–$92,638 a year
16h
Quality Assurance Manager
Confidential —Etobicoke, ON
Advanced degree or certification (e.g., Postgraduate Certificate in Pharmaceutical Regulatory Affairs and Quality Assurance or equivalent) preferred.
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Regulatory Affairs Associate- Contract
Colgate-Palmolive —Toronto, ON
Ensure Regulatory Compliance: Assist in development of regulatory project plans to ensure successful implementation of new regulatory requirements.
12h
Regulatory Affairs Specialist
ct bakery —Mississauga, ON
University degree in Food Science / Nutrition / QA or related degree. Provide resources to implement and maintain the BRC program including GMP and food safety…
$80,000–$85,000 a year
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6d
Senior Manager, Government and Regulatory Affairs
Questrade Financial Group —Toronto, ON
Support the delivery of public affairs strategies to promote the company with public sector audiences, including media relations, digital content development,…
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Manager, Regulatory Affairs
Ipsen Biopharmaceuticals Canada Inc. —Mississauga, ON
Manages the development and implementation of regulatory strategies for all marketed and developmental products.
Manager, CMC Regulatory Affairs
Johnson & Johnson —Toronto, ON
Provides accurate regulatory assessments of chemistry manufacturing and control changes to teams and executes regulatory planning for post approval submissions…
Temporary Employment - Academic Affairs Manager
Niagara University —Vaughan, ON
A valid Canadian driver's license is required that satisfies both University and insurance company underwriting rules and regulations for driving a motor…
$35–$38 an hour
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Project Leader RA, Product Lifecycle Management
Fresenius Kabi Canada —Toronto, ON
Provides strategic input and technical guidance to development teams on regulatory requirements in accordance to the current Health Canada and ICH standards.
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Lead Regulatory Affairs Consultant
Q&C —Mississauga, ON
Our consultants often work closely with marketing, quality assurance, project management and legal teams, so that drug development, filing of submissions and…
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6d
Project Leader Regulatory Affairs, New Product Development
Fresenius Kabi Canada —Toronto, ON
Provides strategic input and technical guidance to development teams on regulatory requirements in accordance with the current Health Canada and ICH standards.
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Manager, Regulatory Affairs
Johnson & Johnson —Toronto, ON
Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes.
Regulatory Affairs Specialist (Hybrid)
Stryker —Hamilton, ON
Develops and executes local regulatory strategies for market authorizations in Canada. We are proud to offer you our total rewards package which includes…
Regulatory Affairs Manager, Team Lead
Nestle Operational Services Worldwide SA —North York, ON
An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets. Manages external service providers and stakeholders…
6d
Sr. Manager, Regulatory Process and Compliance
Alexion Pharmaceuticals,Inc. —Mississauga, ON
The successful candidate will be required to develop and foster strong business relationships with cross-functional stakeholders in Alexion and AstraZeneca, to…
8d
Pharmacovigilance Manager
SRX Health Solutions Inc —Toronto, ON
Foster effective communication and collaboration with cross-functional teams, including regulatory affairs, clinical development, and medical affairs.
Quick apply
Medical Affairs Manager
Medison Pharma —Toronto, ON
In collaboration with the Market Access team, develop strategies to address payer and patient association needs.
Quick apply
Compliance and Regulatory Affairs Specialist
Michel Germain Parfums Ltd. —Toronto, ON
Account programming – review Tier 1 Account’s monthly/seasonal program process and set up; provide product info (sku, price, image, program dates etc) as…
Quick apply
Manager, Formulation Development
Core Healthcare —Toronto, ON
Conduct presentations and writing reports to executive team, describing progress of projects, tracking development activities of on-going projects and achieving…
$100,000–$150,000 a year
Quick apply
VP, Regulatory & Scientific Affairs
EVERSANA —Toronto, ON
Facilitates staff development plans and coordinates with project staffing to ensure that staff is utilized completely and appropriately.
Quick apply
Project Lead, QA Labelling
Fresenius Kabi Canada —Toronto, ON
Under direction of the management, develops the strategies and cascades the appropriate detailed instructions to the associates.
Quick apply
Senior Manager, Regulatory Change - Wealth Governance and Control, Regulatory Affairs
TD Bank —Toronto, ON
The Senior Manager role reports to the AVP, Regulatory Affairs providing leadership in managing a team who provide regulatory advisory support for both…
2d

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Regulatory Affairs Manager

Confidential Etobicoke, ON

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Job details

Full-time 7 days ago

Benefits

Extended health care
Dental care
Paid time off

Skills

Biology
Management
Filing
Microsoft Office
Analysis skills
Bachelor's
Organizational skills
Pharmacy
Chemistry
Computer skills
Leadership
Adobe Acrobat

Full job description

POSITION DESCRIPTION

The Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to achieve product approval while managing a various products portfolio. The Regulatory Affairs Manager ensures compliance with Health Canada regulations, prepares and files regulatory submissions, and builds trust with regulatory contacts.

The Regulatory Affairs Manager is responsible for developing the regulatory strategy of both products approved and products under development, defining regulatory priorities, generating policies and developing action plans.

KEY RESPONSIBILITIES

Review, evaluate, prepare and submit submission to Health Canada and/or the US FDA.
Review technical dossiers for accuracy, completeness and compliance with Regulatory requirements and prepare gap reports.
Ensure that submissions meet format and content requirement as well as ensure the accuracy and completeness of statement, data and conclusion in reports and summaries for inclusion in Regulatory submissions.
Resolve any technical queries or deficiency letters relating to any submission in a timely manner within deadlines.
Responsible for maintaining the required regulatory licences for the company’s activities (DEL, MDEL…)
Serve as the main point of contact as local regulatory representative.
Build and maintain a healthy working relationship with Regulatory Agencies. Use the relationship to understand expectations beyond that which is presented in guidelines and policy statements.
Review, evaluate, prepare and submit responses to Health Canada and FDA requests for clarification/letters of deficiency.
Collaborate with management to provide technical direction and prepare Regulatory strategies for new products under assessment.
Review approved products change controls and determine filing requirements.
Advise on building international regulatory strategies.
Provide regulatory counsel to ensure that all activities comply with regulations. Provide cross-functional input from an operational, scientific and technical viewpoint.
Monitor regulatory maintenance of approved products. Maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) and share knowledge with the department.
Keep abreast of internal and external changes, trends, developments and other dynamic relevant to the regulatory environment that may have an impact on the company products.
Review and approve product labelling to meet regulatory requirements. Review promotional material to ensure compliance to Health Canada regulations and guidelines.
Build and maintain a healthy working relationship with business partners.
Support provincial formulary submissions and drug product listing in co-ordination with Sales and Marketing department.
Maintain a robust pharmacovigilance system by monitoring the adverse events, and ensuring timely and accurate reporting to health authorities and stakeholders.
Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements.

EDUCATION & EXPERIENCE

Bachelor’s degree in Chemistry, Biology, Pharmacy, or related field.
Regulatory Affairs Certification preferred.
A minimum of five years’ experience relevant experience in pharmaceutical Regulatory Affairs with Health Canada.
Proven experience managing regulatory affairs.
Regulatory Affairs experience with FDA preferred

SKILLS & ABILITIES

Results-driven, accountable/own tasks, detail oriented and able to problem-solve with multiple priorities at one time.
Detail oriented, superior problem-solving ability to identify solutions, planning, analytical and organizational skills to manage multiple concurrent projects within established timelines.

Excellent communication (oral and written) and influencing skills; able to interact effectively and confidently both internally and externally.

Proactive with self-discipline and competitive drive
Strong interpersonal skills with ability to work effectively and efficiently.
Strong computer skills including Microsoft Office Suite and Adobe Acrobat.\
Demonstrated leadership skills are strongly preferred.

Job Type: Full-time

Benefits:

Dental care
Extended health care
Paid time off

Schedule:

Day shift
Monday to Friday

Ability to commute/relocate:

Etobicoke, ON M9W 5A3: reliably commute or plan to relocate before starting work (preferred)

Education:

Bachelor's Degree (required)

Experience:

Management: 5 years (required)

Work Location: In person

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regulatory affairs manager jobs in mississauga, on

Regulatory Affairs Manager

Labelling & Change Management Specialist (Contract 18-Months)

Regulatory Affairs Coordinator (On-Site for Bolton, ON)

Testing Support Associate, Molecular Testing

Quality Assurance Manager

Regulatory Affairs Associate- Contract

Regulatory Affairs Specialist

Senior Manager, Government and Regulatory Affairs

Manager, Regulatory Affairs

Manager, CMC Regulatory Affairs

Temporary Employment - Academic Affairs Manager

Project Leader RA, Product Lifecycle Management

Lead Regulatory Affairs Consultant

Project Leader Regulatory Affairs, New Product Development

Manager, Regulatory Affairs

Regulatory Affairs Specialist (Hybrid)

Regulatory Affairs Manager, Team Lead

Sr. Manager, Regulatory Process and Compliance

Pharmacovigilance Manager

Medical Affairs Manager

Compliance and Regulatory Affairs Specialist

Manager, Formulation Development

VP, Regulatory & Scientific Affairs

Project Lead, QA Labelling

Senior Manager, Regulatory Change - Wealth Governance and Control, Regulatory Affairs

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