Regulatory Consultant

2 weeks ago

Québec, Quebec, Canada Syneos Health Full time
Job Title: Regulatory Consultant

Description

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 not only make Syneos Health easier to work with, but to make us 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 to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

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.

Qualifications

What we're looking for

  • BS 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 pro-activity.
  • 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.

What We Offer

At Syneos Health, we believe in 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. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, 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. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $71,820 to $139,600. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

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