Our client is a leading global pharmaceutical company, focused on developing specialty pharmaceutical products to meet unmet medical needs. They are currently looking for a Senior Regulatory Affairs Manager to join their superb Regulatory Affairs team in Toronto, ON.
Reporting to the Pharmaceutical Affairs Director, the Senior Regulatory Affairs Manager will be managing and overseeing Regulatory activities/tasks and strategy for North America, Latin America, and Asia Pacific Regions.
- Manage and implement regulatory strategy for North America, Latin America and Asia Pacific Regions.
- Manage, review, critique, and approve regulatory submission filings for regional regulatory authorities (especially Canada and USA).
- Ensure submissions are filed on timely basis ; regulatory gaps and/or deficiency responses are pre-planned and addressed; and submission approvals are obtained/received as planned.
- Manage the regulatory lifecycle for approved products.
- Work with corporate product development, regulatory, and quality team to ensure CMC portions of the marketed product dossiers are updated and kept current.
- Work with Corporate Regulatory Affairs to ensure submissions and labeling are kept current in the regulatory information management system.
- Manage regulatory responsibility for all clinical studies performed in the region as required.
- Work with cross-functional teams and individuals to facilitate filing of regulatory submissions
- Support, direct and coach subordinate employees.
- Plan and control budgetary expenditures within the regulatory department.
- Identify and implement improvement activities related to regulatory compliance, cost and cycle time.
- Minimum BSc. Science degree (Chemistry, Microbiology, or Pharmacy).
- Minimum 5 years regulatory affairs management experience in submission creation and filing within the pharmaceutical industry.
- Experienced in filing submissions and obtaining approvals within Canada and USA.
- Understanding of pharmaceutical manufacturing processes is a great asset.
- Capable of leading, managing, motivating and engaging employees to perform as a united team to achieve individual and team goals and objectives.
- Possess good judgement and decision-making skills.
- Maintains professionalism at all times.
- Excellent communication skills (verbal and written).
- Experienced in negotiations and addressing deficiencies with regulatory authorities.
- Willingness to continue to learn and educate self on new technologies ; policies ; guidelines.
To apply, please submit your resume using the Apply Now button.
We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.