The Associate, Regulatory Operations, is primarily responsible for the compilation, publishing, and validation of electronic regulatory submissions, including New Drug Submissions (NDS’s), Abbreviated New Drug Submissions (ANDS), Drug Identification Number Submissions, Notifiable Changes, and medical device applications and amendments. The Associate is also responsible for Regulatory Information Management activities and supporting implementation and maintenance activities around publishing.
The Associate, Regulatory Affairs Operations reports into the Director, Regulatory Affairs and is based in Montreal, Quebec.
Works with the Director to authors documents across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with Health Canada eCTD requirements.
Maintains efficient tracking mechanisms (databases and excel sheets) for all regulatory information including the archiving and storage of both electronic and hard copy records.
Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types and maintains the highest level of submission standards.
Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and platform upgrades. Ensures that all functional disciplines are apprised of the changes and trained accordingly.
Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System.
Maintains effective high-profile communications and interactions with colleagues, partners and collaborators as appropriate.
Supports the preparation of high-quality regulatory submissions, including evaluation of data, regulatory strategy and project coordination according to predefined timelines.
Provides other administrative regulatory support as needed
Characteristics of a Good Candidate
1. Analytical and Organizational Skills
2. Negotiation Skills / Teamwork
3. Autonomy / Problem Solving
4. Dealing with Ambiguity
B.Sc. in life science discipline or equivalent
Minimum of 1-3 years within the pharmaceutical industry
Strong knowledge of the Canadian regulations and the proven ability to interpret policies and guidelines
Experience in publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards
Excellent communication skills; written and oral French and English
Strong knowledge of Microsoft Office Suite and Adobe Acrobat
- DESS in drug development
- M.Sc. in drug development /regulatory affairs or clinical development
Benefits of working at Knight
- Competitive salary and bonus plan
- Employee stock option plan
- Employee share purchase plan
- Flexible group insurance plan
- Registered retirement savings plan
To apply, please send your CV to careers_Scientific@gudknight.com
Only selected candidates will be contacted.