Medical Biochemistry jobs

Job Overview
CRL Synergy, one of Canada’s largest and fastest-growing suppliers of control label products, is seeking a detail-oriented and proactive Regulatory Affairs (RAS) Specialist.CRL Synergy is seeking a Regulatory Affairs (RAS) Specialist who can thrive in a fast-paced environment that involves working in an office team environment.

The Regulatory Affairs Specialist is the site lead for all Health Canada submissions and post-market activities covering four product categories sold across Canada:

• Drugs (DIN-assigned OTC)
• Cosmetics
• Medical Devices (Class I–II)
• Natural Health Products (NHPs/NPNs)

The RAS plans, authors, files and maintains regulatory submissions and dossiers, and ensures compliant labelling/advertising.

This role will also provide quality assurance support through maintenance of the RA SOPs, ensuring they are current and implemented, perform data collection, and subsequent analysis.

The successful candidate will provide support for new product development, ensuring Health Canada and customer requirements are being met, including labelling accuracy for new and modified product.

Responsibilities

• Oversight of Pharmacovigilance program

· Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) related to customer complaints.

· Participate in risk management activities and contribute to the development of risk assessment strategies.

• Ensuring accurate record keeping and filing as per organizational procedures.
• Handle clerical and administrative activities.
• Review and assess customer complaints for adverse reactions and reportable incidents. Perform surveillance activities for ongoing product quality and safety.
• Complete Annual Summary Reports and perform screening of scientific literature for product safety information.
• Assisting in updating methods and procedures (SOPs) related to the Quality Management System with a focus on the customer complaint and pharmacovigilance program.

Qualifications

• Bachelor’s degree in a relevant field; advanced degree preferred.
• Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
• Demonstrated skills in project management, including the ability to manage multiple projects simultaneously.
• Strong leadership abilities with experience in supervising teams or mentoring staff.
• Excellent analytical skills with a focus on process improvement methodologies.
• Familiarity with sales or business development processes is a plus.
• Exceptional communication skills, both written and verbal, with the ability to effectively convey complex information to diverse audiences. Join us in making a difference through compliance excellence!

Job Type: Full-time

Pay: $68,000.00-$100,000.00 per year

Benefits:

• Company events
• Dental care
• Disability insurance
• Extended health care
• Life insurance
• On-site gym
• On-site parking
• Paid time off
• Vision care

Education:

• Bachelor's Degree (preferred)

Experience:

• Regulatory Affairs: 2 years (preferred)

Work Location: In person