Join Rockwell Automation as an Analyst ensuring import/export compliance. Focus on regulations, documentation, and shipment monitoring in a hybrid environment.
About the role
- Regulatory Affairs Intern assisting with clinical submissions and chemical manufacturing documentation for pharmaceutical lifecycle support. Providing regulatory assistance and managing project documentation.
Responsibilities
- Support for regulatory submission activities related to clinical operations: converting product monographs into a new format; assisting in the preparation of documents for clinical activities; preparing a response template (question-and-answer document) to address Health Canada requests.
- Support for chemistry, manufacturing and controls (CMC) activities and projects: tasks related to certified product information documents (DCIP); tasks related to applications for pharmaceutical establishment licences (LEPP); assisting in the preparation of documents for CMC activities; preparing a response template (question-and-answer document) to address Health Canada requests.
- Support for labeling and proofing activities: reviewing artwork and proofs required for regulatory filings; maintaining tracking tools, databases, and product registers; supporting Special Access Program activities by preparing supporting documentation for Special Access Program drug requests.
- Regulatory correspondence and archiving of regulatory documents: archiving correspondence and documents in an electronic repository.
- Support for tracking/databases for environmental assessment needs: documentation related to environmental assessment reports.
Requirements
- Must hold a university degree in health sciences or equivalent
- Must excel in communication and time management and be able to work independently with minimal supervision
- Ability to work collaboratively with others (internal and external)
- Strong communication skills to convey and receive information in English and French
- Good organizational skills and ability to prioritize tasks
- Attention to detail and commitment to quality of work
Benefits
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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