Senior Regulatory Affairs Manager Position

Lead regulatory initiatives as a Senior Regulatory Affairs Manager. Focus on strategizing compliance and managing submissions crucial for timely product approvals in the pharmaceutical sector. In this senior-level role, you will be responsible for guiding the regulatory affairs team towards achieving compliance while managing the submission process for new products. Your collaboration with Marketing, Sales, and Quality Assurance teams will be instrumental in streamlining drug development and regulatory operations. You will also support training efforts to enhance team capabilities. Key Responsibilities:

• Lead submissions and labelling activities with Health Canada
• Assess and compile deficiency responses to regulatory inquiries
• Oversee the preparation of regulatory documentation
• Maintain up-to-date Regulatory Operating Procedures
• Conduct regulatory compliance training sessions

Requirements:

• Minimum 5 years in regulatory affairs management
• Strong knowledge of Health Canada submission processes
• Proven ability to manage projects and teams
• Expertise in New Product Assessments and launches
• Excellent communication and coordination abilities

Utilize your leadership and regulatory expertise to foster innovation and drive compliance in drug product development. #J-18808-Ljbffr