Regulatory Affairs Director

2 days ago


Toronto, Ontario, Canada Innomar Strategies Full time
Regulatory Affairs Director/Consultant

At Innomar Strategies, we are seeking a highly skilled Regulatory Affairs Director/Consultant to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical, biologic, and medical device industries.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with international regulations and guidelines.
  • Prepare and submit regulatory documents, including health authority interactions, clinical trial applications, and product approvals.
  • Provide expert advice on regulatory matters, including risk management, labeling, and advertising/promotion.
  • Manage and prioritize multiple projects simultaneously, ensuring timely completion and high-quality deliverables.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies that align with business objectives.
  • Develop and maintain relationships with senior decision-makers at health authorities and regulatory agencies.
  • Stay up-to-date with regulatory developments and provide guidance on emerging trends and issues.
Requirements:
  • Bachelor's degree in life sciences or a related field.
  • Advanced degree in a related field is preferred.
  • Minimum 12 years of experience in regulatory affairs or a related function.
  • Proven track record of successfully managing health authority interactions and regulatory submissions.
  • Strong knowledge of international regulations, including ICH, Health Canada, FDA, and EMA guidelines.
  • Excellent project management and leadership skills.
  • Ability to communicate effectively with cross-functional teams and senior decision-makers.
What We Offer:

We provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This includes support for working families, training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more.



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