Regulatory Consultant

3 weeks ago


Québec, Quebec, Canada Syneos Health Full time
Job Title: Regulatory Consultant

At Syneos Health, we are seeking a highly skilled Regulatory Consultant to join our team. As a Regulatory Consultant, you will be responsible for contributing to the planning and preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD. You will also be responsible for developing and maintaining regulatory systems and infrastructure needed for GRAS.

Key Responsibilities:
  • Contribute to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD.
  • Develop and maintain regulatory systems and infrastructure needed for GRAS.
  • Provide regulatory advice to Company associates.
  • Conduct regulatory research on projects as needed.
  • Provide strategic and operational advice to clients.
  • Arrange, lead, and report on client and regulatory agency meetings.
  • Write IND and product registration dossiers, clinical reports, and other regulatory documents.
Qualifications:
  • BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience.
  • Demonstrated experience in contributing to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
  • Excellent interpersonal/communication skills, including excellent written and verbal communication skills.
  • Excellent customer service skills, with the ability to work both as a team member and independently.
  • Good quality management and budgeting skills.
  • Good people management, project management, problem-solving, and decision-making skills.
  • Advanced skills in Microsoft Office Applications.
What We Offer:
  • A competitive salary range of $71,820 to $139,600.
  • A comprehensive benefits package, including health insurance, 401(k) matching, and paid time off.
  • The opportunity to work with a leading biopharmaceutical solutions organization.
  • A dynamic and supportive work environment.

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