Manager of Regulatory Affairs - Remote

Overview

The Manager of Regulatory Affairs will coordinate and compile regulatory submissions and responses, support regulatory strategies, and maintain communication with internal and external contacts to ensure compliance and successful project outcomes.

In Short

• Coordinate regulatory submissions and agency correspondence.
• Support regulatory strategies in cross-functional teams.
• Identify and resolve client and dossier issues.
• Maintain liaison with clients and agencies.
• Monitor project timelines and budgets.
• Follow best practices and SOPs for quality control.
• Expand professional regulatory knowledge.
• Support client proposals and new business activities.
• Ability to travel as necessary.
• Provide effective consulting services.

Requirements

• B.Sc. in Life Sciences or equivalent experience.
• Certification in Regulatory Affairs (RAC) preferred.
• 5+ years in Regulatory Affairs or related fields.
• Direct experience with regulatory submission types.
• Strong knowledge of Health Authority regulations.
• Effective time management and multi-tasking skills.
• Strong analytical and problem-solving abilities.
• Excellent communication skills.
• Ability to work in a cross-functional team environment.
• Proficient with Microsoft Office and Adobe Acrobat.

Benefits

• Comprehensive medical, dental, and vision care.
• Support for working families, including backup dependent care.
• Paid parental and caregiver leave.
• Training programs and professional development resources.
• Opportunities for mentorship and volunteer activities.
• Inclusive culture and support for wellness.