Regulatory Strategy Director

1 week ago

Quebec City, Canada Syneos Health Full time
About Us

Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Job Overview

We are seeking an experienced Regulatory Strategy Director to join our team. This key role will contribute to the planning and execution of regulatory submissions in assigned regions/countries/projects.

Responsibilities
  • Contribute to the development and implementation of regulatory strategies for pharmaceutical and medical device products.
  • Manage day-to-day project activities, including project teams and projects.
  • Represent the regulatory department with other departments, ensuring effective collaboration and communication.
  • Support business development, generating repeat business from existing clients and developing proposals.
  • Develop, review, and monitor project budgets, as well as client invoicing.
  • Monitor personal utilization and ensure efficient use of resources.
  • Act as a key point of contact for clients and regulatory authorities.
  • Provide regulatory advice to Company associates.
  • Prepare consulting reports and 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
  • Bachelor's degree in a science-related field or equivalent experience in science/regulatory/medical writing-related fields 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 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.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
Compensation and Benefits

The estimated annual salary range for this position is $87,570 to $170,300, depending on qualifications and location. Benefits include company car or car allowance, health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

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