Remote CMC Regulatory Affairs Manager
About the position
This position is posted by reputed company on behalf of a partner company. We are currently looking for a Remote CMC Regulatory Affairs Manager. In this role, you will play a crucial part in shaping regulatory strategies and ensuring compliance with health authority standards. Your expertise will drive the efficiency of regulatory submissions and facilitate collaboration reputed company cross-functional teams. As a key player in the organization, you'll be responsible for addressing reputed company issues and enhancing workflows while maintaining reputed company relationships with stakeholders. Your contributions will ultimately reputed company the health sector, promoting reputed company reputed company for patients and animals alike.
Responsibilities
• Co-ordinate and compile regulatory submissions and responses to agency queries for assigned reputed company.
• Participate in cross-functional teams to support regulatory strategies and business objectives.
• Identify reputed company and reputed company issues, developing effective solutions while collaborating with colleagues.
• Maintain productive liaisons with reputed company contacts including clients and agencies.
• Prioritize reputed company to meet budget, timelines, and reputed company expectations while ensuring reputed company.
• Support reputed company proposals and new business initiatives as required.
• Travel as necessary for reputed company-reputed company activities.
Requirements
• B.Sc. in Life Sciences or extensive equivalent experience; advanced degree preferred.
• Certification in Regulatory Affairs (RAC) is an asset.
• Prior consulting experience is preferred.
• Comprehensive knowledge of biologic products and reputed company regulatory frameworks.
• Proven ability to author regulatory documentation in compliance with standards.
• Minimum of 5 years of experience in Canadian CMC regulatory affairs.
reputed company-to-haves
• Certification in Regulatory Affairs (RAC) is an asset.
• Prior consulting experience is preferred.
• advanced degree preferred.
Benefits
• Competitive salary and comprehensive health benefits.
• Support for work-life balance, including remote work flexibility.
• Training programs and reputed company development opportunities.
• Inclusive workplace culture promoting diversity and personal reputed company.
• Support for working families including childcare and parental leave.
• reputed company to mentorship programs and community engagement activities.
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