Regulatory Affairs Assistant

Prime Health Ltd.; Maple Ridge; On-site; CAD 60,000 - 80,000; Full time

Job summary

A fast-growing health product manufacturing company in Maple Ridge, BC is seeking a full-time Regulatory Affairs Assistant. The role involves preparing regulatory documents, ensuring compliance with regulations, and supporting the regulatory team. Ideal candidates should have a Bachelor's degree in a scientific field and at least 3 years of experience in Regulatory Affairs. The position offers a competitive hourly wage and benefits after the probationary period.

Benefits

Dental care

Disability insurance

Extended health care

Life insurance

Vision care

Qualifications

• At least 3 years of experience in Regulatory Affairs or a related field.
• Strong knowledge of Canadian regulations regarding NHPs and foods.

Responsibilities

• Prepare regulatory documents and submissions for product development.
• Review submission documentation for compliance with Health Canada requirements.
• Assist in evaluating new guidelines and documents.

Skills

Communication

Problem Solving

Attention to Detail

Education

Bachelor’s degree in a related scientific field

Tools

MS Word

Excel

Adobe

Job description

Company Description

Prime Health Ltd. is the fastest growing NNHP (Natural and Non-prescription Health Product) manufacturing company based in Maple Ridge, BC. With a presence in North America, Asia, Middle East, and Latin American countries, we are dedicated to producing high-quality health products that meet the needs of our diverse customer base.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Assistant located in Maple Ridge, BC. The Regulatory Affairs Assistant will be responsible for assisting with the preparation and submission of regulatory documents, monitoring regulatory requirements, ensuring compliance with industry regulations, and maintaining regulatory files and records. Additionally, this role involves supporting the regulatory team with daily tasks, such as updating regulatory databases, conducting regulatory research, and communicating with regulatory authorities.

Job duties & responsibilities

• Prepare the required documentation in the eCTD structure to support product development and registration (labels, finished product specifications, quality, and stability summary report etc)
• 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 the R&D team with respect to regulatory submissions and negotiations.
• Edit and proofread regulatory documentation.
• Assist in preparation and review of labeling, SOP’s, 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.
• Assist in evaluating new guidelines and documents and applying them.
• Additional tasks may be assigned from time to time as required by management.

Qualifications

• Bachelor’s degree in a related scientific field.
• At least 3 years of experience in Regulatory Affairs or a related field within the pharmaceutical or nutraceutical industry.
• Strong knowledge of Canadian regulations, including Natural Health Products (NHPs), foods, meal replacements, cosmetics, labeling, and advertising requirements.
• Proven ability to analyze scientific literature and summarize findings in technical reports.
• Excellent verbal and written communication skills in English.
• Proficient in MS Word, Excel, Adobe, and Windows-based applications.
• Highly organized, with strong prioritization skills, attention to detail, and a process-oriented approach.
• Effective problem-solving abilities and capable of handling complex issues.
• Self-motivated, dependable, and a committed team player.
• Ability to multitask and meet tight deadlines while maintaining confidentiality and professionalism.

Salary: $23 to $28 Hourly (based on experience)

Job location: Maple Ridge, BC

Job type: Full-time permanent

Benefits: After probationary period

• Dental care
• Disability insurance
• Extended health care
• Life insurance
• Vision care