Regulatory Compliance Specialist

6 days ago


Mississauga, Ontario, Canada Pharma Medica Research Inc. Full time

About Pharma Medica Research Inc.

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Pharma Medica Research Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special populations and patient groups. Our team is passionate about delivering exceptional results and is actively seeking a Regulatory Compliance Specialist to join our Mississauga location.

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This role involves assisting in corporate compliance activities of the Quality Assurance Department at Pharma Medica Research Inc. The position reports to the Manager, CSV & Compliance and/or designate.

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Duties and Responsibilities:

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  • Provide training to staff on regulatory compliance and company procedures (i.e., Quality System, Privacy Policies).
  • Assist in developing, maintaining, and implementing corporate compliance training programs.
  • Administer and maintain applicable ePMRI applications (i.e., eSOP, eTraining etc.).
  • Conduct internal audits ensuring compliance to SOPs and regulatory requirements.
  • Collaborate with departments to create a positive attitude towards regulatory compliance.
  • Maintain archive material (i.e., documents, study retention drugs, electronic media) including submissions, retrievals, storage, and disposal.
  • Other duties as required.
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Required Skills and Qualifications:

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  • Bachelor's degree in a scientific, healthcare, or pharmaceutical field, or equivalent combination of education and related experience.
  • 1-3 years of related experience in quality assurance and/or regulatory roles.
  • Knowledge of relevant regulations (i.e., GLP, GCP, Privacy, 21 CFR Part 11).
  • Excellent communication and interpersonal skills.
  • Possess enthusiasm and effective training capabilities.
  • Work independently and as part of a team.
  • Effective organizational skills.
  • Proficiency in regulatory requirements and other governing body regulations.
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Benefits:

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  • Competitive salary range: $60,000 - $80,000 per annum.
  • A benefit plan fully paid by PMRI, including health care, dental care, vision care, LTD, life insurance, AD&D, health spending account and wellness spending account.
  • Opportunities for advancement and career progression.
  • Generous employee milestones award program.
  • Corporate discounts program.
  • Friendly atmosphere, culture of learning.
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Please note that all applicants must be eligible to work in Canada.



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