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The Senior Regulatory Affairs Specialist’s 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
- Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
- Where appropriate, act as the CMC regulatory lead to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of post-approval changes
- Author/compile/submit post-approval change supplements
- 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
- Provides mentorship for entry-level and intermediate-level regulatory associates
Essential Functions
- Authoring, organization, and preparation of electronic (eCTD) regulatory filings; also includes peer review of filings.
- Understand, identify potential regulatory risks and recommend 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.
- Process, interpret and provide recommendations for complex, unusual issues.
- Critically review documentation for regulatory submissions and provide input for necessary revisions.
- 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.).
Requirements
- Bachelor Degree in scientific discipline required or equivalent work experience.
- 5 or more years of Regulatory experience or related field. RAC certification preferred.
- 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 software system to manage change controls.
- Strong background using Microsoft Office tools and Adobe Acrobat.
- Travel Time Required – up to 10% (May vary depending on region/site).
Working Conditions:
- Standard office environment.
- Willingness to work in a team-based environment.
- Close attention to detail required.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties.
- The position deals with many deadlines. Due to the short turnaround time of deadlines and limited time, overtime, weekend work and holiday work is sometimes required.
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