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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