To Apply for this Job Click Here
The Regulatory Affairs Associate responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and support of Regulatory activities including but not limited to:
- Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
- Assist with CMC regulatory impact regulatory strategy for post-approval changes proposed at the manufacturing site
- Preparation information and technical data needed for support of post-approval changes
- Author/review updates to marketed product labeling
- Maintain regulatory knowledge of current guidelines and regulations
- Maintain current regulatory databases and produce various reports as needed
- Utilize and support electronic document management system
Essential Functions
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings
- Assist with identification of potential regulatory risks and recommended strategies based on current FDA/health authority requirements
- Manage multiple priorities
- Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
- Critically review documentation for regulatory submissions and provide input for necessary revisions.
Requirements
- Bachelor Degree in scientific discipline required or equivalent work experience.
- Minimum of 1-2 years of Regulatory experience or related field.
- Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required.
- Project leadership or supervisory experience is preferred.
- Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
- Excellent written and oral communication skills.
- Use of change controls software system.
- Strong background using Microsoft Office tools and Adobe Acrobat.
