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Reporting to the QA Manager, the Regulatory Affairs and Quality Assurance Associate supports the following programs: regulatory affairs, change control and review of artwork.
Support our clients’ documentary requirements for their regulatory filings;
Serve as the liaison between the client and the various parties involved at Confab to carry out the regulatory plan and incorporate chemistry, manufacturing and control (CMC) documents for filings;
Act as a contact person on matters of “regulatory requirements”;
Keep the various groups within Confab apprised of any changes in guidelines or regulatory policy in Canada, the United States or any other relevant territory with an impact on Confab’s operations;
Participate in client meetings during discussions concerning regulatory matters;
Ensure monitoring and delivery of the client’s regulatory plan according to schedule;
Arrange the renewal of establishment and operating licenses annually;
Manage the DINs and NHPs belonging to Confab.
Bachelor of science or equivalent;
Minimum 5 years’ experience in regulatory affairs in the pharmaceutical industry;
Strong working knowledge of regulatory requirements with regard to chemistry and manufacturing for filings with the FDA (CBE30, PAS, ANDA and NDA) or Health Canada;
Bilingualism, spoken and written;
Ability to work together with a multidisciplinary team;
Strong communication skills, both spoken and written;
Ability to work on multiple projects simultaneously and with varying deadlines.
Confab Laboratories is part of Mylan Pharmaceuticals ULC, one of the largest pharmaceutical companies in the world with over 35,000 employees across 165 countries.
Confab specializes in the development and manufacturing of non-sterile pharmaceutical drugs (CDMO). The plant, located on the south shore of Montreal, is growing with major expansion investments underway to support an increasing volume of R&D projects as well as pioneering new dosage forms.
The company complies with both Canadian and US regulatory requirements. To know more about Confab Laboratories please visit the website at http://www.confab.com/
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