Senior Regulatory Affairs Associate

BLES Biochemicals Inc.; London; Hybrid; CAD 85,000 - 110,000; Full time

Benefits offered by this job

Pension match

Healthcare & dental

Collaborative environment

Life-saving product

Job summary

BLES Biochemicals Inc. is seeking a Senior Regulatory Affairs Associate to oversee lifecycle maintenance of drug and medical device registrations in Canada and internationally. This remote-hybrid role involves coordinating with cross-functional teams and occasional travel to London, Ontario.

You will ensure compliance with global health regulations, prepare submissions, and monitor regulatory changes to support products throughout their lifecycle.

Qualifications

• University degree in Life Sciences (biology, chemistry, pharmacology, or a related field).
• Post-graduate Certification in Regulatory Affairs.
• 3–5 years of hands-on regulatory affairs experience in pharmaceuticals, biologics, or medical devices.

Responsibilities

• Submissions management: Prepare, compile, file, and monitor biologic drug product and medical device submissions for international markets with limited supervision.
• Health Canada submissions: Prepare submissions for Health Canada in the eCTD format, including Notifiable Changes, annual reports, and renewals.
• Regulatory tracking: Monitor Health Canada, ICH, and other international regulatory sources for guidelines affecting drugs and devices.
• Change evaluation: Evaluate impact of quality and manufacturing changes and new regulations on registered products globally.
• Material review: Review marketing and promotional materials.
• Document control: Maintain regulatory electronic files at BLES Biochemicals.
• Support: Assist Head of International Regulatory Affairs.

Skills

Regulatory affairs

Lifecycle management

Cross-functional collaboration

Regulatory tracking

Education

Life Sciences degree

Regulatory Affairs Certification

Job description

About BLES Biochemicals

BLES Biochemicals Inc. is a privately-owned, proudly Canadian pharmaceutical and medical device manufacturer and distributor. Our pharmaceutical product, BLES®, is a life-saving pulmonary surfactant used to treat premature infants who have respiratory distress syndrome. BLES® was discovered at Western University and continues to be manufactured in London, Ontario. In 2015, BLES® was ranked among the top five discoveries at an Ontario university, alongside insulin. Our product is the market-leading surfactant in Canada and several other countries, and treats tens of thousands of patients annually.

Our product portfolio also includes a medical device, BLEScath® Intratracheal Catheter, used to administer BLES®. The team at BLES Biochemicals works hard to manufacture exceptional products; the welfare and happiness of patients and their families are our top priorities. Our vision is to live in a world where every premature baby has access to life-saving pulmonary surfactant therapy. There is still a long way to go, and we hope that you’ll join us on this journey.

Job Overview

The Senior Regulatory Affairs Associate is responsible for lifecycle maintenance of drug product and medical device registrations in Canada and internationally. Working closely with the business, marketing, and other operational teams, you will ensure compliance with applicable global health regulations while meeting key business objectives. This is a remote-hybrid position. The successful candidate should be able to travel to London periodically.

Key Responsibilities

• Submissions Management: Prepare, compile, file, and monitor biologic drug product and medical device submissions for international markets with limited supervision.
• Health Canada Submissions: Assist with preparing submissions for Health Canada in the eCTD format, including Notifiable Changes, annual reports, and renewals.
• Regulatory Tracking: Track domestic and international health regulatory sources (Health Canada, ICH, and other relevant international sources) for emerging regulatory guidelines for both drug products and medical devices.
• Change Evaluation: Evaluate the impact of proposed quality and manufacturing changes, as well as the impact of new or revised regulations and guidelines on registered products globally.
• Material Review: Assist in the review of marketing and promotional materials.
• Document Control: Maintain all regulatory electronic files at BLES Biochemicals.
• Support: Carry out other duties as required by the Head of International Regulatory Affairs.

Qualifications & Experience

• Education: University degree in Life Sciences (biology, chemistry, pharmacology, or a related field).
• Certification: Post-graduate Certification in Regulatory Affairs.
• Experience: Minimum of 3–5 years of hands-on regulatory affairs experience in pharmaceuticals, biologics, or medical devices.

Benefits & Compensation

We offer a competitive compensation package designed to support your personal and professional well-being, including:

• Company matching pension program.
• Comprehensive healthcare and dental coverage.
• A collaborative, supportive, and friendly working environment.
• The opportunity to work with a dedicated team producing a world-class, life-saving product.