Pharmaceutical Regulatory Affairs Specialist

2 weeks ago

Calgary, Canada CRL Synergy Full time

**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.

**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

Pay: $68,000.00-$80,000.00 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

  • Regulatory Affairs Specialist

    1 week ago

    Calgary, Canada Circle Cardiovascular Imaging Full time

    Do you want to join a diverse and global team that is revolutionizing the cardiovascular healthcare industry? Circle CVI is hiring! **About Circle Cardiovascular Imaging** Circle Cardiovascular Imaging Inc. (Circle CVI) is revolutionizing the medical technology industry by developing world-class and advanced post-processing solutions for cardiovascular and...

  • Regulatory Affairs Specialist

    1 week ago

    Calgary, Alberta, Canada Fluid Biomed Inc. Full time $90,000 - $120,000 per year

    This is a full-time opportunity to join the team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.Position Summary:As a...

  • Senior Regulatory Writer

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Complete Regulatory | An IPG Health Company Full time

    Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Complete Regulatory | An IPG Health Company Senior Talent Acquisition Partner at IPG Health Medical Communications Who we are: Complete Regulatory, part of IPG Health Medical Communications, is home to over 500 experts across some of the world’s most awarded...

  • Advisor Regulatory Affairs

    2 weeks ago

    Calgary, Canada Enbridge Full time

    **Posting End Date**: November 08, 2024 **Employee Type**: Regular-Full time **Union/Non**: This is a non-union position We are seeking an Advisor Regulatory Affairs to join our team! The primary focus of this role is leading, organizing, monitoring, and making regulatory filings related to operations and maintenance activities and routine projects. We...

  • Remote Regulatory Affairs Director

    2 weeks ago

    Calgary, AB, Canada Phantom Compliance Full time

    Compliance Manager Position Type: Full-Time, 1 vacancy  Hours of Work: Monday to Friday, 9:00 am to 5:00pm, 40 hours per week, MST We are a one‑stop compliance powerhouse trusted by clients who expect precision, agility, and results. We run like a championship sports team where every player knows their role, every move is strategic, and winning...

  • Global Regulatory Affairs Manager CMC

    4 weeks ago

    Montreal, Toronto, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Alphanumeric Systems Full time

    Alphanumeric is hiring a Global Regulatory Affairs Manager CMC, to work remotely in Montreal or Toronto with one of the biggest pharmaceutical manufacturing companies in the world.Please be aware that we can only hire people already based in Canada with fully legal and valid documentation to work in Canada. Please apply with your CV in English, as some of...

  • Pharmaceutical Sales Representative

    5 days ago

    Calgary, Canada BioSyent Pharma Inc Full time

    **Pharmaceutical Sales Representative - Calgary North Territory** Are you passionate about driving sales in a competitive environment? If you are a driven individual with an entrepreneurial spirit in the pharmaceutical industry, then we want to hear from you! We’re BioSyent and we are looking for **an ambitious Pharmaceutical Sales Representative** to...

  • Pharmaceutical Sales Specialist – Prescriber Relations

    3 weeks ago

    Calgary, Canada Peak Pharma Solutions Inc. Full time

    Pharmaceutical Sales Specialist – Prescriber Relations & Deployment You’re bold, energetic, and very resourceful, especially when results are at stake. You have what it takes: a competitive drive coupled with the exceptional ability to communicate the value behind our client’s products/services and build lasting relationships with healthcare...

  • Coordinator, Regulatory and External Affair

    1 week ago

    Calgary, Canada TRANS-NORTHERN PIPELINES Full time

    **ABOUT US** Trans-Northern Pipelines Inc. (TNPI) operates regulated pipelines to safely transport the refined petroleum products (gasoline, diesel, aviation, and heating fuel) used by Canadian businesses and consumers every day. These pipelines connect refineries in Edmonton to Calgary, including the Calgary International Airport; and refineries in...

  • Director, Regulatory Affairs

    4 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada CBCRadio-Canada Full time

    Director, Regulatory Affairs (Telework/Hybrid) Join to apply for the Director, Regulatory Affairs (Telework/Hybrid) role at CBC/Radio-Canada. Position Title: Director, Regulatory Affairs (Telework/Hybrid) Status of Employment: Permanent Position Language Requirement: English, French Language Skills: English (Reading), English (Speaking), English (Writing),...