Regulatory affairs specialist Jobs

Pharmaceutical Regulatory Affairs Specialist
CRL Synergy —Calgary, AB
- $68,000–$100,000 a year
- Full-time
- Sales
- Business development
- Analysis skills
- Disability insurance
- Dental care
Quick apply
Part-Time QA & Regulatory Affairs Specialist Supplements, Natural Health Products & Foods
Blue Ocean Regulatory —Remote
- $35–$45 an hour
- Part-time
- Remote
- Writing skills
- Bachelor's
- Quality Control
- Work from home
- Flexible schedule
Quick apply
Regulatory Affairs Specialist
Medtronic —Brampton, ON
- $73,520–$91,900 a year
- Full-time
- Bachelor's
5d
Regulatory Affairs Specialist (Hybrid)
Kardium Inc. —Burnaby, BC
- $87,000–$91,000 a year
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Dental care
Quick apply
3d
Regulatory and Scientific Affairs Specialist
Natural Factors —Coquitlam, BC
- $65,500–$82,000 a year
- Full-time
- Bachelor's
- Commuter benefits
13d
Regulatory Affairs Specialist
Brenntag Canada Inc. —Mississauga, ON
- Full-time
- English
- Business
- Communication skills
- Dental care
- Tuition reimbursement
Quick apply
1d
Canada Senior Licensing Specialist Civil, Regulatory Affairs
GE Vernova —Markham, ON
- $115,000–$165,000 a year
- Full-time
- Engineering
- Master's degree
- Bachelor's
- Relocation assistance

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Canada Senior Licensing Specialist Civil, Regulatory Affairs
GE Vernova —Markham, ON
Support preparation and submittal of Preliminary Safety Analysis Report (PSAR), Pre-Operational Safety Analysis Report (POSAR) and Final Safety Analysis Report…
$115,000–$165,000 a year

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Pharmaceutical Regulatory Affairs Specialist

CRL Synergy
Calgary, AB

Quick apply

Job details

Full-time
$68,000–$100,000 a year

Qualifications

Sales
Filing
Process improvement
Business development
Analysis skills
Supervising experience
Project management
Bachelor's
Communication skills

Full job description

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

Quick apply

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Pharmaceutical Regulatory Affairs Specialist

Part-Time QA & Regulatory Affairs Specialist Supplements, Natural Health Products & Foods