Regulatory Manager

1 month ago


Quebec City, Canada Syneos Health Full time

About the Role

We are seeking a highly skilled Regulatory Manager to join our team at Syneos Health. As a key member of our regulatory department, you will be responsible for contributing to the planning and preparation of regulatory submissions, managing project teams, and providing regulatory advice to clients and internal stakeholders.

Key Responsibilities

  • Contribute to the preparation of regulatory submissions, including INDs, PMAs, NDAs, and CTDs.
  • Manage project teams and ensure timely completion of projects.
  • Provide regulatory advice to clients and internal stakeholders.
  • Develop and maintain relationships with regulatory authorities and clients.
  • Stay up-to-date with regulatory requirements and changes.
  • Collaborate with cross-functional teams to ensure regulatory compliance.

Requirements

  • BS degree in a science-related field or equivalent experience.
  • Comprehensive regulatory knowledge and experience in contributing to the preparation of regulatory submissions.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Fluent in speaking, writing, and reading English.

About Syneos Health

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We are committed to providing an environment and culture in which our employees can thrive, develop, and advance. We offer a competitive salary range of $71,820 to $139,600, a company car or car allowance, health benefits, and a quality-of-life balance.


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