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

CMC Regulatory Affairs Manager, Submission Excellence & Project Management
AstraZeneca —Mississauga, ON
You will also develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions.
Pay information not provided
3d
Senior Manager, Regulatory Affairs
Synaptive Medical Inc. —Toronto, ON
You will own regulatory filing strategy and submission for SMI’s products and will lead your team in the development of content for regulatory filing for…
Pay information not provided
Quick apply
1h
Case Manager
Critical Trauma Therapy —Greater Toronto Area, ON
All applicants must have a valid driver’s license, access to a reliable vehicle and be willing to travel. We are a dynamic, multidisciplinary company providing…
Pay information not provided
Quick apply
12d
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.
Manager, Regulatory Affairs
Ipsen Biopharmaceuticals Canada Inc. —Mississauga, ON
Manages the development and implementation of regulatory strategies for all marketed and developmental products.
Pay information not provided
General Manager, Canada
Jazz Pharmaceuticals —Mississauga, ON
Experience from working collaboratively and cross-functionally with marketing brand teams, market research, market access, sales, medical affairs, business…
$260,000–$390,000 a year
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.
Pay information not provided
Refrigeration and Design Engineer
Due North —Halton Hills, ON
Design and develop commercial refrigerators and freezers from concept, through design, prototyping, testing, certification, and manufacturing.
$85,000–$120,000 a year
Quick apply
Project Coordinator, Real Estate
Canada Lands Company | La Société immobilière du Canada —Toronto, ON
Assists in the preparation of cash projections and revenue and expenditure forecast for the annual 5-year Corporate Plan, monthly financial statements; analyzes…
Pay information not provided
11d
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…
Pay information not provided
Quick apply
RFP & Contracts Manager
BAXTER —Mississauga, ON
Responsible for the development, implementation, and maintenance of contracts for region respective customers. Bilingual both English and French.
Pay information not provided
Internal Audit Manager - Enterprise Services and Public Affairs (ESPA)
Citi —Mississauga, ON
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its…
5d
Quality Assurance Associate - Fixed Term
Sentrex Distribution Inc. —Markham, ON
Maintain site documentation control and records retention for all local forms, work instructions, SOP's, and warehouse documentation.
Pay information not provided
4d
Supervisor Government Affairs
Independent Electricity System Operator (IESO) —Toronto, ON
Meet/communicate/confer with senior staff from various business units on issues that affect IESO business and legislative objectives and the current policy…
Pay information not provided
6d
Junior Product Developer, Food Manufacturing
Skjodt-Barrett Foods —Brampton, ON
Collaborate. You will be part of a product development project team working closely with Sales Account Managers and customers, Marketing, Quality Assurance,…
Pay information not provided
Quick apply
10d
Regulatory Manager
Open Farm —Toronto, ON
You have a Bachelor’s degree in food science, Regulatory Affairs, or related field. Develop and implement strategies to ensure compliance with import and export…
Pay information not provided
Regulatory Officer-Licencing and Regulatory Approvals
Nuclear Waste Management Organization —Toronto, ON
Supporting the Senior Advisor of Regulatory Affairs, this candidate will lead and author regulatory deliverables and ensure compliance of submissions by…
Pay information not provided
C&Q Execution Manager
Pharmeng Technology Inc —Toronto, ON
The ideal candidate will have extensive CQ experience and will be responsible for coordinating activities between workstreams, identifying and mitigating risks,…
Pay information not provided
Quick apply
Clinical Project Coordinator
Everest Clinical Research-Can —Markham, ON
Assist the Project Manager Lead in integrating information to develop project budgets for each in-scope service and assisting in the development and maintenance…
Pay information not provided
Quick apply
13d
Forecasting Manager
Apotex Inc. —North York, ON
Lead key cross-functional groups meetings (Marketing, Sales, Operations, IP, Regulatory Affairs) to both maintain up-to-date market assumptions, and provide…
Pay information not provided
Coordinator, Compliance / Coordonnateur.trice, conformité
College of Immigration and Citizenship Consultants —Burlington, ON
Si nous communiquons avec vous au sujet d’une occasion d’emploi et que vous avez besoin d’une mesure d’adaptation en raison d’un handicap, nous nous ferons un…
Pay information not provided
Quick apply
13d
Manager, Medical Science Liaison (Cross-TA) ( GTA/ MTL )
GSK —Mississauga, ON
Take ownership to ensure the medical therapy team develops and delivers the Medical Affairs Plans, including key data generation plans, scientific engagement…
Pay information not provided
3d
Food Chemistry Specialist
AGAT Laboratories —Mississauga, ON
The successful candidate will be responsible for the method development, validation and participating in the accreditation assessment process, then eventually…
Pay information not provided
Quick apply
Patient Safety IT Product Lead
AstraZeneca —Mississauga, ON
Educational Background: Bachelor’s or Master’s degree in health sciences, Information Technology, or a related field.
Pay information not provided
5d
Analyst - External Affairs (12 month contract)
Kinross Gold Corporation —Toronto, ON
The global external affairs function serves to support Kinross’ business and operations, to ensure we maintain our social license to operate in each of our…
Pay information not provided
5d

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CMC Regulatory Affairs Manager, Submission Excellence & Project Management

AstraZeneca Mississauga, ON

Apply Now

Job details

Full-time 3 days ago

Skills

PMP
Master's degree
Project management
Bachelor's
Pharmacy
Manufacturing

Full job description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The Role:

Join us at AstraZeneca as a CMC Regulatory Affairs Manager Submission Excellence and Project Manager. In this role, you will manage all aspects related to the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.

They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, mentorship, policy, and processes.

Accountabilities:

As a CMC RA Manager, you will manage the timely preparation and delivery of CMC contributions to regulatory submissions linked to medicinal products throughout their lifecycle, with emphasis on clinical programs, and also including marketing authorization applications and all post approval activities. You will deliver submission quality CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures. You will ensure that publishing tools are in place and perform publishing of the CMC sections in a timely manner. You will also develop and build expertise in regional regulatory requirements to ensure compliance of CMC submissions. You will give advice, train and mentor other team members. You will train others in procedures and practices relating to Veeva. Additionally, you will be responsible for change management as assigned and conduct activities consistent with Company Values and in compliance with the Code of Ethics.

Essential Skills/Experience:

Bachelors degree in Science, Regulatory Sciences or Pharmacy.
2 years experience in Regulatory/Drug development (Industry or Health Authority)
Breadth of knowledge of manufacturing, project, technical and regulatory management.
IT Skills
Stakeholder & Project management
Professional capabilities: Regulatory knowledg

Desirable Skills/Experience:

Masters degree in Science, Regulatory Sciences or Pharmacy
4 years experience in Regulatory/Drug development (Industry or Health Authority)
Knowledge of the drug development process and regulatory submissions
Understanding of current regulatory CMC requirements
Direct/indirect Regulatory Affairs CMC experience with clinical submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products
Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
Lean capabilities

At AstraZeneca, we are driven by innovation and originality. We work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We see change as an opportunity, embracing the possibility to learn, grow and evolve. We are striving for technology adoption and automation to drive efficiencies and new innovations. Here we have the ability and autonomy to be an agent of change.

Ready to make a difference? Apply now and join us in our mission to bring hope and solutions to patients across the globe!

Great People want to Work with us! Find out why:

GTAA Top Employer Award for 10 years
Top 100 Employers Award
Canada’s Most Admired Corporate Culture
Learn more about working with us in Canada
View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

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Apply Now

regulatory affairs manager jobs in mississauga, on

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

The Role:

They will ensure the application of global CMC regulations and guidance within AstraZeneca and lead/contribute to development of new guidance, mentorship, policy, and processes.

Accountabilities:

Essential Skills/Experience:

Bachelors degree in Science, Regulatory Sciences or Pharmacy.

2 years experience in Regulatory/Drug development (Industry or Health Authority)

Breadth of knowledge of manufacturing, project, technical and regulatory management.

IT Skills

Stakeholder & Project management

Professional capabilities: Regulatory knowledg

Desirable Skills/Experience:

Masters degree in Science, Regulatory Sciences or Pharmacy

4 years experience in Regulatory/Drug development (Industry or Health Authority)

Knowledge of the drug development process and regulatory submissions

Understanding of current regulatory CMC requirements

Direct/indirect Regulatory Affairs CMC experience with clinical submissions for Synthetics and/or biologic and biotechnology derived products such as monoclonal antibodies or sophisticated biologic products

Understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies

Lean capabilities

Ready to make a difference? Apply now and join us in our mission to bring hope and solutions to patients across the globe!

Great People want to Work with us! Find out why:

GTAA Top Employer Award for 10 years

Top 100 Employers Award

Canada’s Most Admired Corporate Culture

Learn more about working with us in Canada

View our YouTube channel

Are you interested in working at AZ, apply today!