Regulatory Affairs Specialist

The Regulatory Affairs Product Specialist responsibilities encompass the support of US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. 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 and assess CMC regulatory impact of post-approval changes proposed at the manufacturing site and provide regulatory strategy
• Plan/author/compile/submit/manage variations and supplements for marketed products within and outside the United States
• Participate in cross-functional teams and provide health authority requirements 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
• Provide mentorship for entry-level regulatory associates

Work schedule: Monday - Friday 8am - 5pm

• 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
• Understand and identify 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.

• Bachelor Degree in scientific discipline required or equivalent work experience.
• Minimum of 3 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 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.

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.