Regulatory Affairs Director

4 weeks ago

Québec, Quebec, Canada Syneos Health Full time
Job Title: Associate Director, Regulatory Affairs

At Syneos Health, we are seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.

Key Responsibilities:
  • Contribute to the planning and execution of regulatory submissions, including INDs, product registrations, and post-approval maintenance activities.
  • Manage project teams and ensure timely completion of regulatory submissions.
  • Act as a representative of the regulatory department with other departments and external stakeholders.
  • Support business development, including proposal development and client relationship management.
  • Develop and review project budgets and client invoicing.
  • Monitor personal utilization and ensure efficient use of resources.
  • Provide regulatory advice to Company associates and clients.
  • Prepare consulting reports and provide strategic and operational advice to clients.
  • Arrange, lead, and report on client and regulatory agency meetings.
  • Write regulatory documents, including IND and product registration dossiers, clinical reports, and other regulatory submissions.
Requirements:
  • Bachelor's degree in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
  • Modest experience in regulatory affairs, including contributing to the preparation of regulatory submissions.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
  • Excellent interpersonal and communication skills, including written and verbal communication.
  • Excellent customer service skills, with the ability to work both as a team member and independently.
  • Good quality management and budgeting skills.
  • Good project management, problem-solving, and decision-making skills.
  • Advanced skills in Microsoft Office Applications.
What We Offer:
  • A competitive annual base salary ranging from $87,570 to $170,300.
  • A company car or car allowance.
  • Health benefits, including medical, dental, and vision.
  • A 401(k) plan with company match.
  • Eligibility to participate in the Employee Stock Purchase Plan.
  • Eligibility to earn commissions/bonus based on company and individual performance.
  • Flexible paid time off (PTO) and sick time.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

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