Regulatory Affairs Associate

5 days ago

Pickering, Ontario, Canada Nanz Pharma Full time US$80,000 - US$120,000 per year

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

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