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 as one of the top five discoveries at an Ontario university, alongside insulin. Our product is the market-leading surfactant in Canada and several other countries, and it treats tens of thousands of patients annually.

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 Responsibilities:

- Prepare, compile, file and monitor biologic drug product and medical device submissions for international markets with limited supervision.




- Assist in the preparation of submissions for Health Canada in the eCTD format, including Notifiable Changes, annual reports, and renewals.
- 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.
- 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.
- Assist in the review of marketing and promotional materials.
- Maintain all regulatory electronic files at BLES Biochemicals.
- Other duties as required by the Head.

Qualifications:

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

Pay: $70,000.00-$80,000.00 per year

Advantages

- Company pension
- Dental care

Work Location: Hybrid remote in London, ON N5V 3K4

📌 Senior Regulatory Affairs Associate (London)
🏢 BLES Biochemicals
📍 London