Current jobs related to Regulatory Affairs Manager - Oakville - Quadra

  • Regulatory Affairs Intern

    1 week ago

    Oakville, Canada UCB Full time

    **Make your mark for patients** We are looking for a **Regulatory Affairs Intern**to join us in our **Regulatory Affairs Team** based out of our **Oakville, ON** office (hybrid, 2 days per week onsite). **About the role** The primary responsibility of this position is to assist in the compilation and maintenance of regulatory submission documentation to...

  • Regulatory Affairs Specialist

    6 days ago

    Oakville, Canada Natus Medical Incorporated Full time

    **Regulatory Affairs Specialist (12-Month Contract - Hybrid Role)**: **Location: Oakville, Ontario, Canada** **Work Arrangement: Hybrid - must be able to commute to our Oakville Office** **Contract Length: 12 -15 month** **About the Role**: We’re currently seeking a **Regulatory Affairs Specialist** for a 12-15month contract position to support our EU MDR...

  • Manager, Regulatory Affairs

    2 weeks ago

    Oakville, Canada AmerisourceBergen Full time

    - What you will be doing Why choose Innomar Strategies_ - _ “Remote-First” culture - flexible opportunities to work from home!_ - _ Competitive Total Rewards Package:_ - _ Base salary + bonus programs_ - _ RRSP matching_ - _ Employee Share Purchase Plan_ - _ Flexible benefits program (in effect on day one), including:_ - _ Healthcare Spending Account_ -...

  • Regulatory Affairs Specialist

    2 weeks ago

    Oakville, Canada Natus Medical Incorporated Full time

    **Regulatory Affairs Specialist** **Welcome to Natus Medical Incorporated**: We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment...

  • Manager, Public Affairs

    1 week ago

    Oakville, Canada Andrew Peller Limited Full time

    Manager, Public Affairs & Commercial Development Job Description #BeExtraordinary At Andrew Peller Limited (APL), our mission is to be Canada’s #1 branded wine and craft beverage company by delivering the perfect brand experience for every lifestyle and occasion. Through our commitment to excellence, honouring our roots, owning it, fostering belonging...

  • Manager- Medical and Scientific Affairs

    3 weeks ago

    Oakville, Canada Xediton Pharmaceuticals Inc. Full time

    Xediton is a specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. We are committed to developing, partnering, and making available new and established medicines to promote the health of Canadians. We are located in Oakville, Ontario. Manager - Medical and Scientific Affairs Key Responsibilities and...

  • Public Affairs

    2 days ago

    Oakville, Canada Essity Full time

    **Public Affairs & Market Access Manager** **Who We Are** Essity is a global leader in health and hygiene with our corporate headquarters in Stockholm, Sweden, and North American headquarters in Philadelphia, PA. We are a multi-billion-dollar company that is committed to breaking barriers to well-being. Essity does this through innovative brands in the...

  • Medical Affairs Coordinator

    2 days ago

    Oakville, Canada Insulet Corporation Full time

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. - We...

  • Regulatory Operations Associate

    4 weeks ago

    Oakville, Canada Cencora Full time

    Join to apply for the Associate, Regulatory Operations role at Cencora Responsibilities Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients. Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients. Use, manage...

  • Associate, Regulatory Operations

    3 weeks ago

    Oakville, Canada World Courier Inc. Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

Regulatory Affairs Manager

2 weeks ago

Oakville, Canada Quadra Full time

**Position**: Regulatory Affairs Manager

**Location**: Based out of Burlington, Ontario or Vaudreuil-Dorion, Quebec (Hybrid / Flexibility Policy)

**Status**: Permanent, full-time

As a strong regulatory manager, you will bring your comprehensive knowledge of regulatory compliance, meticulous attention to detail, and strong analytical skills to ensure our organization's adherence to regulatory requirements. In this role, you will have the opportunity to lead and inspire a talented team, fostering a culture of excellence and driving successful outcomes. By joining our team as a Regulatory Affairs Manager, you will be instrumental in shaping the future of our organization and making a positive difference for our valued clients.

About your future team
At Quadra, we put people first so that together, we can reimagine the possibilities.
Based in Burlington, Ontario or Vaudreuil-Dorion, Quebec, our modern head office is home to over a hundred fun-loving professionals. Of course, you can always take advantage of our hybrid telecommuting policy. Founded over 45 years ago, Quadra is dedicated to its 550+ employees located in Canada and the United States. Quadra Chemicals is one of the largest distributors of chemicals and ingredients in the Canadian marketplace. With multiple facilities across Canada, we are committed to delivering excellence in everything we do. We are a rapidly growing company with a long-term commitment to our employees. If you are committed to excellence, you belong at Quadra. At Quadra, we have created an environment where people are a priority and opportunities are growing. Our culture based on our core values of entrepreneurship, innovation and caring make us an employer of choice.

We believe in fostering a work environment that challenges and empowers individuals, providing ample opportunities for personal growth and development. We recognize and celebrate outstanding performance, ensuring that your dedication and achievements are duly acknowledged.

What will you bring to the team?
- A strong technical knowledge of pertinent government regulations and associated compliance requirements as well as insight in determining compliance pathways for new business areas developed by the company
- Being an active member with industry associations, including, but not limited to, participation on the Responsible Distribution Canada’s and NACD
- Excels in managing priorities, is resourceful and a relationship-builder
- Being known as a positive leader that works well with cross-functional teams (QA, Sales, Operations, etc.)
- Being acknowledged by peers as an expert in order to respond to external requests related to regulatory affairs
- Excellent communicator, focused on customer service, curious and eager to achieve excellence for his/her team
- Strong attention to detail, accuracy and precision
- A passion for the industry with a desire to share with your peers

**You would be responsible for**:
**Team Management**:

- Leading department workflow to ensure a structured approach to compliance activity
- Ensuring that regulatory compliance activity meets all government requirements, and that department output is meeting Quadra’s commercial needs for efficient integration of compliance oversight in business operations
- Supervision of team members; establish departmental goals, action plans and strategies as well as mentoring/coaching, managing performance, hiring, onboarding, etc.
- Work in collaboration with the Director, Compliance Assurance to establish department goals and objectives

New Product Regulatory Evaluation and Set-Up, Ongoing Regulation Compliance:

- Development and implementation of efficient Regulatory Affairs procedures to determine the CEPA/TSCA status of all new products and the identity of product ingredients
- Mentoring the Regulatory Affairs team regarding CEPA new substance screening activities
- Managing new product screening procedures that encompass compliance with many other product use regulations which reflect the wide diversity of industry sectors served: Food & Drugs Act and associated regulations, Transportation of Dangerous Goods Regulations, Drug Precursor Regulations, Explosive Regulations, WHMIS/GHS and additional Quadra internal requirements such as product High Risk classification
- Management of new product set-up workflow to facilitate a robust and efficient compliance program
- Product Registration Activity: Preparation and submission of pertinent product use approval submissions (i.e. NSN, fertilizers, animal feeds, pesticides, biocides, Food & Drug related use approvals, etc.)
- Management of regulation compliance (for existing regulations) to include procedure revisions when regulations are updated

CEPA and TSCA Substances Management
- Monitoring of Canada Gazette and other industry association resources to identify government mandated reporting activities associated with chemical product importation and sales
- Supervising Quadra Significant New A