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Regulatory Affairs Director

2 months ago

Toronto, Ontario, Canada Innomar Strategies Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs Director to join our team at Innomar Strategies. As a key member of our management team, you will be responsible for directing and managing the affairs of our company, ensuring compliance with regulatory requirements and maintaining positive relationships with internal and external stakeholders.

Key Responsibilities
  • Regulatory Compliance: Develop and maintain a deep understanding of regulatory requirements and ensure compliance with all relevant laws and regulations.
  • Client Relationships: Build and maintain strong relationships with clients, including interfacing with potential clients and agencies, and providing exceptional customer service.
  • Project Management: Lead and participate in project teams, ensuring timely completion of projects and effective communication with stakeholders.
  • Regulatory Affairs: Facilitate CMC regulatory affairs activities for pharmaceutical, biologics, and natural health product clients, including regulatory submissions, assessments, and agency meetings.
  • Team Leadership: Develop and manage regulatory direct reports, including assignment delegation, time and budget management, and skill and knowledge development.
Requirements
  • Education: B.Sc. / M.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry, or Pharmacy).
  • Experience: 10-15 years direct CMC experience in Regulatory Affairs, including biologics, within the pharmaceutical industry.
  • Leadership Skills: Proven leadership abilities in a cross-functional, multi-disciplinary team environment.
  • Skills: Effective project and people management skills, strategic planning and problem-solving skills, and strong business and financial acumen.
What We Offer

We provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness, including support for working families, training programs, and professional development resources.

Equal Employment Opportunity

Innomar Strategies is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.