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| » Job Details | Go Back |
| Job Title: Regulatory Affairs Associate sr level |
| Description |
| Regulatory Affairs Associate
Location: Mississauga
Industry: Pharmaceutical
Job Summary:
Responsible for compilation and submission of dossiers for registration of products. Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.
Description:
• Responsible for the preparation, peer review, maintenance and timely completion of regulatory documents to support submissions to various markets
• Prepare and peer review labelling, product monographs and marketing materials
• Act as designate for Project Leader. Assist in review of change control documents.
• Assist in product launch activities as required
• Prepare, Interpret and ensure compliance with SOPs, RA policies and procedures and regulatory guidelines
• Perform additional duties as assigned by RA Project Leader
• Interact with other applicable departments within the company to discuss and provide solutions to regulatory issues and/or problems
• Communicate with external sources (agents and suppliers) to request and/or provide data relevant to submissions
• Seeks guidance from Project Leader and Manager
• Assist in training of more junior staff and creates a teamwork environment
Requirements:
• BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences
• Diploma from a RA program would be an asset
• Minimum 3-5 years pharmaceutical experience in an RA role
• Good oral / written communication, organizational and interpersonal skills
• Attention to detail
• Demonstrates leadership and interpersonal skills
• Computer literate; Proficiency with MS Office
|
| Details |
| Job Ref: |
Regulatory Affairs Associate sr level |
| Hours: |
Full Time |
| Location: |
Mississauga, Ontario, Canada |
| Working Term: |
Permanent |
| Salary: |
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