Regulatory Assistant
Maple Ridge, BC, Canada
Job Description
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Our Organization Prime Health Ltd is a fastest growing nutraceutical manufacturing company based in Maple Ridge, BC having presence in North America, Asia, Middle East and Latin American countries. We are passionate in delivering result and customer satisfaction. To boost our growth, we are looking for Regulatory Assistant who can contribute in the following activities. Job duties & responsibilities
- Prepare required documentation in the eCTD structure to support product development and registration (labels, finished product specifications, quality, and stability summary report.
- Prepare responses to deficiency letters (Notices of Non-Compliance, Notices of Deficiency, Screening Deficiency Notices ) in a timely manner with minimal guidance.
- Perform thorough reviews of submission documentation for compliance with Health Canada requirements.
- Prepare product labelling (including Product Monographs and nutrition tables)
- Work closely with R&D team with respect to regulatory submissions and negotiations.
- Edit and proofread regulatory documentation.
- Assist in preparation and review of labeling, SOP\xe2\x80\x99s, and other departmental documents.
- Remain up to date on applicable regulatory guidelines (Health Canada, ICH, etc.).
- Develop departmental working guidelines to document standard processes in the department.
- Any other duties as assigned by the Regulatory Affairs Manager.
- Assist in evaluating new guidelines and documents and applying them.
- At least University Degree in a related scientific field.
- Minimum 1 \xe2\x80\x93 2 years of experience in Regulatory Affairs or related field in any pharmaceutical or nutraceutical company.
- Sound knowledge of Canadian regulations including NHPs, foods, meal replacements, cosmetics, labelling, and advertising requirements.
- Strong ability to analyze scientific literature and summarize in technical reports.
- Excellent verbal and written English skills.
- Proficient in computer programs including MS Word and Excel, Adobe and Windows.
- Strong organizational skills including effective prioritization, follow-up, and process oriented.
- Problem solving capabilities with capacity to manage complex issues. Highly motivated, committed to the team and dependable.
- Able to multitask and meet competing deadlines. Protect confidential information with a high degree of diplomacy.
- Protect confidential information with a high degree of diplomacy
- Casual dress
- Dental care
- Disability insurance
- Extended health care
- Life insurance
- On-site parking
- Vision care
- Day shift
- Monday to Friday
- Maple Ridge, BC V2X 0Y4: reliably commute or plan to relocate before starting work (required)
- Bachelor\'s Degree (required)
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Job Detail
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Job IdJD2145082
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMaple Ridge, BC, Canada
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EducationNot mentioned