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Job Post Details

Senior Regulatory Affairs Associate - job post

BLES Biochemicals Inc.
London, ON N5V 3K4•Hybrid work
$70,000–$80,000 a year - Permanent, Full-time

Job details

Pay

  • $70,000–$80,000 a year

Job type

  • Permanent
  • Full-time

Location

London, ON N5V 3K4•Hybrid work

Benefits

Pulled from the full job description

  • Dental care
  • Company pension

Full job description

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

Benefits:

  • Company pension
  • Dental care

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

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