Regulatory Affairs Specialist 4

Company: Katalyst HealthCares & Life Sciences
Location: Franklin
Posted on: May 27, 2023

Job Description:

Job Description
R esponsibilities:

• Works with RA Manager and Platform Leaders to ensure timely execution of regulatory strategies with business objectives and customer results
• Assesses regulatory pathways for new products, product modifications or product conversions; develops regulatory strategies and planning for submissions or support of customers' regulatory submissions
• Partners with and supports Pharma customers in securing timely development, submissions, addressing health authority questions and regulatory drug-device combination products approvals
• Performs regulatory impact assessment of changes linked to the field of expertise and assigned platform
• Liaises with cross-functional and cross company teams to meet customer needs in driving new drug delivery solutions for global markets
• Develops and maintains knowledge & awareness on assigned fields of expertise: identify applicable regulations and standards, perform regulatory intelligence/watch, educate appropriate contact partners
• Identifies and communicates potential risks and mitigations associated with regulatory strategies to partners
• Support to customers for regulatory advice and registration of their products and interact as necessary with the U.S. regulatory agencies and EU Notified Bodies
• Reviews and/or approves product marketing claims and communication, Advertising/promotional materials, and labeling
• Conduct trainings on regulatory issues for staff and for business stakeholders (e.g., Platform, R&D, Marketing and Pharma Partners)
• Participates in internal/external trade, professional, and standards development organizations
• Manages multiple projects with minimal supervision Requirements:
  • Knowledge in medical devices regulation registration requirements and pathways (variations, renewals, supplements), in the US and EU markets. Pharmaceutical experience is a plus.
  • Understanding of product development cycle and quality management systems
  • Experience in meeting with, making presentations to, and negotiating with leadership and/or regulators
  • Ability to use your time productively and efficiently (structured and self-organized with strong project management skills)
  • Ability to resolve problems and to make appropriate regulatory decisions under pressure
  • Ability to adapt, multitask and respond quickly in a rapidly changing and often ambiguous environment, Strong team player.
  • Ability to drive and maintain favorable customer experience and customer-centricity (internal & external)
  • B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry). Advanced degree preferred.
  • Minimum five years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device, biologic, or pharmaceutical fields
  • Demonstrated project management, negotiation, influencing and communication skills.

Keywords: Katalyst HealthCares & Life Sciences, Franklin , Regulatory Affairs Specialist 4, Other , Franklin, Tennessee