The Opportunity is Yours!
Regulatory Affairs Associate
Pharmaceutical Company- London
BLES Biochemicals Inc.,www.BLESbiochem.com,seeks a Regulatory Affairs Associate for our London location. BLES Biochemicals Inc., manufactures and distributes a biologic drug product BLES® (bovine lipid extract surfactant). BLES® is a pulmonary surfactant for use in the treatment of premature infants suffering from neonatal respiratory distress syndrome (NRDS). BLES® is unique; there is no generic form of this product.
BLES Biochemicals Inc. is a privately-owned, Canadian-controlled pharmaceutical company. It is the market leader for pulmonary surfactant in Canada.
The Regulatory Affairs Associate’s responsibilities include:
- Assist in preparation of submissions for international markets, monitor submission progress and respond to correspondence in requisite time frame.
- Obtain regulatory documents and ensure they are legalized in accordance with the requirements of the countries to which they are destined.
- Assist in the preparation of submissions for Health Canada (e.g. Notifiable Changes).
- Retrieve, file and submit Adverse Drug Reports and Mandatory Problem Reports to Health Canada.
- Assist in preparation of Periodic Safety Update Reports (PSUR).
- Monitor the Health Canada, ICH and other relevant international databases for updated regulatory guidance documents.
- Perform on-going monitoring of scientific literature.
- Maintain all regulatory electronic files at BLES Biochemicals.
If you have:
- Post Graduate Certification in Regulatory Affairs.
- University Degree in Life Sciences.
- Knowledge of Canadian Food and Drug Regulationsfor human pharmaceuticals.
- Proficient skills in MS Office Suite programs and Acrobat.
- Familiarity with eCTD submissions (asset)
- The ability to work and cooperate with others to accomplish group, and corporate goals and objectives.
- The ability to manage several projects at once while setting specific goals and timelines for completion.
- Good analytics and problem-solving skills.
- Attention to detail.
- Strong time management skills.
- Excellent communication skills, both written and verbal.
And are willing to roll up your sleeves and take on any challenge to help this company continue to produce a world class product, work with a great team, and receive a competitive compensation package, then we would like to talk to you.
Please reply in confidence with a cover letter to our HR Specialist, Jenny Mellor by replying to this post.
BLES Biochemicals welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Job Type: Full-time
- Regulatory Affairs: 2 years (Preferred)