Regulatory Consultant

1 month ago

Québec, Quebec, Canada Syneos Health Full time
About the Role

We are seeking a highly skilled Regulatory Consultant 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 execution of regulatory submissions in assigned regions and countries.

Key Responsibilities
  • Contribute to the preparation of regulatory submissions, including INDs, PMAs, NDAs, and CTDs.
  • Manage day-to-day operations of project teams and projects, including line management responsibilities for staff members.
  • 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, review, and monitor project budgets and client invoicing.
  • Monitor personal utilization and utilization of direct reports.
  • Provide regulatory advice to Company associates and conduct regulatory research as needed.
  • 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
  • BS degree in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
  • Demonstrated experience in contributing to the preparation of regulatory submissions, including electronic submissions.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and 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 people management, project management, problem-solving, and decision-making skills.
  • Advanced skills in Microsoft Office Applications.
About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives. Discover what our 29,000 employees, across 110 countries, already know: WORK HERE MATTERS EVERYWHERE.

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