Senior Regulatory Affairs Manager - REMOTE

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Manager - REMOTE. In this role, you will be crucial in coordinating and compiling regulatory submissions while also ensuring compliance with health authority standards. Your expertise will help improve internal processes and foster productive relationships with both internal teams and external regulatory agencies.

You'll be part of a forward-thinking team committed to creating healthier futures for individuals and pets alike. This position offers you the opportunity to make a significant impact on regulatory strategy in the health care products industry.

• Co-ordinate and compile regulatory submissions and responses to agency questions
• Implement action plans for timely approval of regulatory submissions
• Participate in and support project teams effectively
• Recognize client and dossier issues and develop strategies to address them
• Maintain communication with internal and external contacts for project updates
• Ensure projects meet budget timelines and client expectations
• Handle quality control of documentation and data
• Enhance professional regulatory knowledge (Health Canada and FDA)
• Support client proposals and new business activities as required
• Train or mentor junior team members to enhance overall expertise
• Proactively improve business processes and tools

• B.Sc. in Life Sciences or equivalent experience, advanced degree preferred
• Certification in Regulatory Affairs (RAC) preferred
• 5-8 years of relevant experience in Regulatory Affairs or related fields
• Experience with a variety of health care products including Biologics and Cosmetics
• Strong knowledge of local Health Authority regulations
• Well-organized with strong time management skills
• Excellent problem-solving and project management capabilities
• Strong analytical and mathematical skills
• Proficient in MS Office, Adobe Professional, and Veeva Vault

• Comprehensive medical, dental, and vision care
• Support for working families including backup care and adoption assistance
• Behavioral health solutions and paid parental leave
• Opportunities for professional development and training
• Mentorship programs and volunteer activities
• Inclusive company culture promoting personal growth