Director Of Regulatory Affairs - Medical Device/Pharma
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
This is on site, 5 days a week role – for Canada, Scarborough location.
Director Of Regulatory Affairs
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
Preparing and submitting regulatory submissions:
Director, Legal & Privacy Jobs
By Coast Capital Savings At Surrey, British Columbia, Canada
Proficient business, organizational and project management skills.
Participates in cross-functional organization and management committees, including the Operational Risk Committee and Incident Response Team.
Oversees and manages litigation, dispute resolution and corporate insurance.
Advanced legal analytical skills and problem-solving skills.
Strong written and verbal communication skills, including legal drafting.
Proficient knowledge of MS Excel, Word, Outlook and PowerPoint.
Head Pharmaceutical Quality And Regulatory Affairs, Pni And Genomic Medicines
By Pall Corporation At Vancouver, British Columbia, Canada
In depth knowledge of regulatory requirements, i.e., GMP, Health Canada, EU, and FDA and experience with GMP documentation review.
Designing, implementing, harmonizing and systemically reviewing the Cytiva Pharma Quality Management System (QMS), starting with PNI.
Accountable for Quality Governance, Quality Escalation and Quality Management Review processes.
Manage Regulatory and Quality personnel in accordance with Company talent management practices. Train, mentor, and coach the staff within the department
Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.
Participate in any issues that require management escalations