Regulatory Strategy Director

1 week ago

Quebec City, Canada Syneos Health Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Associate Director to join our team at Syneos Health. This individual will be responsible for contributing to the planning of regulatory submissions, managing project teams, and acting as a representative of the regulatory department.

The ideal candidate will have comprehensive regulatory knowledge and understanding of pharmaceutical and medical device product development. They will possess excellent interpersonal and communication skills, with the ability to work both independently and as part of a team.

About Us:

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.

Responsibilities:

  • Contributes to the preparation of regulatory submissions, including INDs, PMAs, NDAs, MAAs, and CTDs.
  • Manages day-to-day activities of project teams and projects.
  • Acts as a representative of the regulatory department with other departments.
  • Supports business development through repeat business from existing clients and proposal development.
  • Develops, reviews, and monitors project budgets and client invoicing.
  • Monitors personal utilization.
  • Acts as a key point of contact for clients and regulatory authorities.
  • Provides regulatory advice to Company associates.
  • Prepares consulting reports.
  • Provides strategic and operational advice to clients.
  • Arranges, leads, and reports on client and regulatory agency meetings.
  • Writes regulatory documents and manages project teams for regulatory submissions.
  • Contributes to the development of policies, goals, objectives, plans, and procedures.
  • Acts as a resource for technical knowledge and provides thought leadership in the area of expertise.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of regulatory systems needed for GRAS.
  • Develops a reputation for the Company as an industry leader in Regulatory by attending and speaking at industry events.

Qualifications:

  • Bachelor's degree in a science-related field or equivalent experience in science/regulatory/medical writing-related fields.
  • Demonstrated experience in contributing to the preparation of regulatory submissions.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and medical device product development.
  • Excellent interpersonal and communication skills.
  • Ability to work independently and as part of a team.
  • Good quality management and budgeting skills.
  • Good project management, problem-solving, and decision-making skills.
  • Advanced skills in Microsoft Office Applications.

Benefits:

Syneos Health offers a competitive salary ranging from $87,570 to $170,300 per year, depending on qualifications and experience. Additionally, the Company provides benefits such as company car or car allowance, health benefits, 401k matching, 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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