(Contractor) Senior Regulatory Affairs Specialist

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

• 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.).

• 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.