Regulatory Affairs Manager - China

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Updated: Today
Location: Morrisville, NC, United States
Job ID: 6530

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Overview

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Responsibilities

You’ll join The Scientific and Medical Affairs Advisory Group within Syneos Health Consulting. Where you will help make Life Science organizations more effective, particularly in complex specialty markets, while giving products the strategic support they require. More specifically:

Responsible for day to day management of project teams and projects. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.

  • 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 clinical trial and product registration dossiers, clinical reports, and other medical documents. Manages project teams and preparation of regulatory submissions for conduct of clinical trials, product registration, 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 GRC
  • 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.

Job Requirements

  • Minimum BS degree, preferably an MS or PHD in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
  • Pharmaceutical or medical device related experience with a focus on regulatory strategy and submissions
  • Demonstrated experience in contributing to the preparation of regulatory submissions including electronic submissions.
  • Experience working in an independent office environment, and in a complex multi-process oriented environment in general preferred.
  • Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
  • Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently.
  • Excellent written and verbal communication skills.
  • Good quality management and budgeting skills.
  • Good people management, project management, problem-solving, and decision-making skills.
  • Computer literacy in MS Word, Excel, and PowerPoint.
  • Ability to interact with staff from multiple departments and offices to establish project standards.
  • Good initiative, adaptability, and pro-activity.
  • Good attention to detail, flexibility, and open to suggestions.
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic

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