Manager / Sr. Manager / AD, Regulatory Affairs

Paragon Bioservices   •  

Baltimore, MD

8 - 10 years

Posted 244 days ago

This job is no longer available.

Key Responsibilities include, but are not limited to:

  • Support our clients with required documents for CMC sections of regulatory submissions.
  • Determine and communicate submission and approval requirements early in the product lifecycle to assure that project plans are aligned with submission strategies and regulatory guidelines.
  • Write and review regulatory documents with a critical eye for suitability for submissions to FDA and any other regulatory agencies as need be.
  • Under the direction of the VP of Quality and Regulatory Affairs, handle the preparation of submission packages for regulatory agencies in compliance with applicable requirements & best practices. Identify issues early in the submission preparation process that could impact timelines/risks.
  • Participate in multidisciplinary project teams within the client providing guidance and direction on current regulatory pathways and expectations. 
  • Assist with the companies progress into commercial readiness efforts
  • Stay current on changes to the regulatory environment that could impact Paragon’s contract manufacturing strategies. 
  • Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. 

Experience & Education: 

  • Bachelor's Degree in a scientific or engineering discipline
  • 7 or more years in Regulatory Affairs in the area of Biologics
    • Experience in the hands-on preparation of IND, IMPD or BLA submissions for Biological products
    • Interactions with the US, Canadian, European, and other international regulatory authorities
    • Prior facilitation of face-to-face meetings with regulators
    • Ability to build credibility and influence internal departments and client representatives
    • Experience in working with regulatory consultants and contract research organizations 
    • Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project)
    • Strong organizational and project management skills

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