Regulatory Affairs Associate

1 week ago

Pickering, Ontario, Canada Nanz Pharma Full time

Company Description

Nanz Pharma is a globally respected pharmaceutical organization committed to innovation, excellence, and community service. We aim to improve lives with our hygiene and wellness products and strive to be a global leader in the field. Our vision is to provide high-quality products at affordable prices, fostering trust, quality, and brilliance with our customers, partners, and employees.

Role Description

The Regulatory Affairs Associate at Nanz Pharma is responsible for ensuring compliance with regulatory requirements and supporting the preparation, submission, and maintenance of regulatory filings. This role involves coordinating with internal teams to compile technical documents, tracking regulatory submissions, and staying updated with evolving health authority guidelines. The ideal candidate will have a strong understanding of pharmaceutical regulations, attention to detail, and the ability to work in a fast-paced environment. Additionally, this position offers exposure to global regulatory strategies and interactions with health agencies to facilitate product approvals and compliance.

Roles & Responsibilities:

  • The RA/QA Associate is responsible for assisting in regulatory product submissions.
  • Assist with monthly and annual reporting to all regulatory bodies.
  • Assist in writing responses to regulatory bodies.
  • Generate and investigate deviations and non-conformance reports. Identify and implement Corrective Actions.
  • Assist in the creation of validation protocols and requalification programs. Coordinate and perform the test activities necessary to execute the validations. Review and summarize the results and conclusions of the validation.
  • Review applicable literature to conduct assessments of safety and efficacy. Compile and prepare reports based on findings.
  • Update, develop SOPs, and ensure timely implementation of the SOPs. Working with quality software's like QMS and ERP
  • Review batch records, Certificates of Analysis (CofAs), and other GMP documentation.
  • Perform plant walkthroughs/audits and enforce SOPs/GMP requirements.
  • Perform line clearance, start of batch procedures, sample collection, and end of batch reconciliation.
  • Complete routine logbook entries as assigned by the RA/QA manager.
  • Follow up on issues (e.g., GDP errors, OOS test results, etc.).
  • Provide training to new hires or other employees as required.
  • Assist the RA/QA manager in performing gap assessments of draft regulations to ensure remediation prior to regulations coming into effect.
  • Prepare and participate in monthly management review meetings and take minutes.
  • Other duties as assigned

Education & Experience

  • Bachelor/Master's degree in science, pharmaceutical, Regulatory Science, Business, or a related discipline preferred, or relevant working experience.
  • Minimum 1 year of professional related experience in Regulatory Affairs within Cannabis, pharmaceutical, or NHPs.
  • Knowledge in chemistry and manufacturing, labeling relating to drug products. Knowledge of the Food and Drug Act, Title 21 CFR, and EU-GMP.
  • Ability to adapt and interpret regulations from regulatory bodies worldwide

Requirements

  • Ability to pass an RCMP security clearance.
  • Excellent oral and written communication skills. Fluent in English.
  • Demonstrated strategic, process-driven, analytical, and critical thinking skills.
  • Ability to work in a highly organized manner where attention to detail, accuracy, and confidentiality are critical.
  • Proven time management skills and the ability to effectively manage multiple tasks of varying complexity with conflicting priorities in a busy working environment.
  • Motivated and driven individual.
  • Demonstrated ability to influence and work with all levels across the organization.
  • Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).

Job Type:
Full-time

Schedule:

  • 8-hour shift
  • Monday to Friday

Experience:

  • ERP systems: 1 year (required)
  • QMS: 1 year (required)
  • Work Location: In person

  • Documentation Clerk

    1 week ago

    Pickering, Ontario, Canada Extendicare Full time

    Job DescriptionKey Responsibilities: Maintains the master schedule for the Nursing Department and all associatedresponsibilities for replacement of staff; Works directly with Charge Nurses and Director of Care/Associate Director of Careto provide adequate nursing staff for the home as predicted by the needs; Under the direction of the Director of Care or...

  • Nuclear Quality Assurance Manager

    2 weeks ago

    Pickering, Ontario, Canada Tetra Tech Full time

    Discover your full potential. At Tetra Tech, we are collaborating with industry-leading experts for a sustainable future for our world. We combine consulting and engineering with advanced analytics and technology to solve the world's most complex challenges. Our innovation hubs across the globe will enable you to share ideas and best practices while growing...

  • Series Lead

    5 days ago

    Pickering, Ontario, Canada AtkinsRéalis Full time

    OverviewAtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are proud to be the steward of Canadian CANDU nuclear technology.The Series Lead is charged with the planning of the work for an...

  • Regulatory Affairs Supervisor

    5 days ago

    Pickering, ON LW K, Canada Nanz Pharma Full time

    Overview: We are seeking a highly skilled Regulatory Affairs Supervisor to lead our regulatory compliance initiatives within the pharmaceutical, biotech, and natural health product (NHP) sectors. The ideal candidate will possess extensive knowledge of FDA, Health Canada, and ICH guidelines, along with strong experience in CMC, regulatory submissions, and...

  • Technical Quality Assurance Associate

    2 weeks ago

    Pickering, Canada BTNX Inc. Full time

    **Company Overview** BTNX Inc. (BTNX) is a biotechnology company and a world leader in rapid, point-of-care diagnostics. We specialize in innovation, research, development, and manufacturing of advanced in-vitro diagnostic (IVD) tests for laboratories, clinics, hospitals, and physician offices. Headquartered in Pickering, ON, BTNX’s core business...

  • Standards Coordinator

    3 days ago

    Pickering, Canada Nanz Pharma Full time

    Education: - Expérience: - **Education**: - Bachelor's degree - ** Tasks**: - Analyze and provide advice on the managerial methods and organization of an establishment - Conduct quality audits - Develop quality management and quality assurance standards - Conduct research to determine efficiency and effectiveness of managerial policies and programs -...

  • Project Executive

    7 days ago

    Pickering, Canada 3S INTERNATIONAL INC Full time

    Education: Bachelor's degree - Experience: 5 years or more **Work setting**: - Relocation costs covered by employer - Construction - Manufacturing or production - International affairs **Budgetary responsibility**: - $100,001 - $500,000 **Tasks**: - Allocate material, human and financial resources to implement organizational policies and programs -...

  • Manager, Credit Evaluation, Premium

    6 days ago

    Pickering, Canada Standard Bank of South Africa Limited Full time

    Business Segment: Business & Commercial Banking To ensure the effective value adding risk management of Credit Evaluation, managing and enhancing the approval of credit applications for Business Banking customers within acceptable parameters, in order for Business and Commercial Banking, to achieve asset growth targets, whilst maintaining a...

  • Safety, Health

    7 days ago

    Pickering, Canada AECOM Full time

    Company Description Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the...

  • Senior Solid Waste Engineer

    1 week ago

    Pickering, Canada R.J. Burnside & Associates Limited Full time

    Are you an accomplished Solid Waste Engineer seeking an exciting new challenge? R.J. Burnside & Associates Limited (Burnside) invites you to join our innovative solid waste management team, preferably based in Pickering, however we are ready to consider our other offices for the right candidate.You will play a pivotal role in providing technical leadership...

  • Senior Solid Waste Engineer

    2 weeks ago

    Pickering, Canada R.J. Burnside & Associates Limited Full time

    Are you an accomplished Solid Waste Engineer seeking an exciting new challenge? R.J. Burnside & Associates Limited (Burnside) invites you to join our innovative solid waste management team, preferably based in Pickering, however we are ready to consider our other offices for the right candidate. You will play a pivotal role in providing technical leadership...

  • Human Factors Engineer

    3 weeks ago

    Pickering, Canada Cpus Engineering Staffing Solutions Inc. Full time

    Overview We are currently requesting resumes for the following position: Human Factors Engineer Resume Due Date : Tuesday, July 22, 2025 (5:00PM EST) Job ID : 25-119 Number of Vacancies : 1 Level : MP4 Duration : 36 Months Hours of work : 35 Hours per week Location : Temp – 889 Brock Road, Pickering, Base – CHQ on rotating schedule Work Mode : Hybrid –...

  • Human Factors Engineer

    3 weeks ago

    Pickering, Canada Cpus Engineering Staffing Solutions Inc. Full time

    Overview We are currently requesting resumes for the following position: Human Factors Engineer - Resume Due Date: Tuesday, July 22, 2025 (5:00PM EST) - Job ID: 25-119 - Number of Vacancies: 1 - Level: MP4 - Duration: 36 Months - Hours of work: 35 Hours per week - Location: Temp – 889 Brock Road, Pickering, Base – CHQ on rotating schedule - Work...