Careers at BLES Biochemicals
Senior Regulatory Affairs Associate
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.
Compensation
$70,000.00 - $80,000.00 per year