Summary of PositionThe 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.
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Job Segment: Regulatory Affairs, Compliance, Document Management, Medical Technologist, Legal, Technology, Entry Level, Healthcare
