Regulatory Consultant Specialist

1 month ago

Quebec City, Canada Syneos Health Full time

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.



Job Overview


We are seeking an experienced Regulatory Consultant Specialist to contribute to the planning for regulatory submissions in assigned regions/countries/projects. This role will be responsible for day-to-day management of project teams and projects, including line management responsibilities for staff members.



Key Responsibilities



  • Contributes to planning for regulatory submissions in assigned region/country/project.
  • Responsible for day-to-day management of project teams and projects.
  • Line management responsibilities for staff members.
  • Acts as a representative of the regulatory department with other departments.
  • Supports business development, including generation of repeat business from existing clients and proposal development.
  • Develops, reviews, and monitors project budgets; reviews client invoicing.
  • Monitors personal utilization and utilization of direct reports.
  • Acts as a key point of contact for clients and regulatory authorities.
  • Provides regulatory advice to Company associates.
  • Conducts regulatory research on projects as needed.
  • Provides strategic and operational advice to clients.
  • Arranges, leads, and reports on client and regulatory agency meetings.
  • Writes IND and product registration dossiers, clinical reports, and other regulatory documents.
  • Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post-approval maintenance activities.
  • Acts as a resource for technical knowledge.
  • Participates in quality improvement efforts to increase overall operational efficiency.
  • Contributes to the building of regulatory systems and infrastructure needed for GRAS.
  • Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
  • Develops solutions to complex problems.
  • Provides internal training in appropriate areas of expertise to other departments.


Requirements



  • Bachelor's degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience.
  • Demonstrated experience in contributing to the preparation of regulatory submissions, including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development.
  • Excellent interpersonal/communication skills, including excellent written and verbal communication skills.
  • 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.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative, adaptability, and proactivity.
  • Strong analytical skills, good attention to detail.
  • Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
  • Fluent in speaking, writing, and reading English.


Compensation and Benefits


The annual base salary for this position ranges from $71,820 to $139,600. The company offers a comprehensive benefits package, including health benefits, 401(k) matching, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO) and sick time.



About Working at Syneos Health


Syneos Health is committed to 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. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

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