Regulatory Intelligence Manager

Vor 4 Tagen

Wien, Wien, Österreich Syneos Health Vollzeit
Job Summary

Syneos Health is seeking a highly skilled Regulatory Intelligence Manager to join our team. As a key member of our Regulatory Intelligence Department, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulations.

Key Responsibilities
  • Collect and maintain clinical regulatory intelligence in our Regulatory Intelligence System (RIS), ensuring that country-specific regulatory requirements are current and accurate.
  • Interact with external and internal experts to collect country and region-specific regulatory intelligence, and work closely with Country SMEs to understand the local regulatory landscape.
  • Conduct searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
  • Understand applicable local, national, and regional regulations and translate them into organizational best practices.
  • Document the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs.
  • Review surveillance alerts and queries and determine actions to be taken through to implementation.
  • Advises, consults, and makes final recommendations to all aspects of clinical regulatory intelligence.
Requirements
  • BS degree or equivalent demonstrated experience in a relevant field.
  • Clinical research experience required, including significant regulatory intelligence experience or regulatory affairs or regulatory operations, preferably from a clinical research organization.
  • Good knowledge of country-specific and regional regulations.
  • Ability to analyze information across multiple sources and manage substantial amounts of details.
  • Strong research skills required to support routine surveillance activities to detect, monitor, and synthesize complex regulatory information.
  • Ability to react to internal and external changes, trends, and development in the regulatory environment that may impact Syneos Health.
  • Knowledge of niche regulatory topics preferred.
  • Excellent interpersonal and communication skills.
  • Fluency in speaking, writing, and reading English.
  • Exercises judgment within defined procedures and practices to determine proper action.
  • Excellent customer service skills, with the ability to work both within teams and independently.
  • Good people management, project management, problem-solving, and decision-making skills.
  • Good initiative, adaptability, and pro-activity.
What We Offer

Syneos Health offers a competitive salary range of $71,820 to $139,600 USD, a 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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