The Regulatory Affairs Project Manager will support regulatory affairs in formulation and execution of regulatory strategy and authoring of regulatory documents for submission to various Health Authorities. This includes providing support for all activities related to Health Authority meetings, requests for information and other queries from Health Authorities and other Regulatory Intelligence activities. The Regulatory Affairs Project Manager will be responsible for interpreting regulatory guidances and relaying key points to regulatory affairs and senior leadership. This position is also responsible providing training and mentoring to junior staff.

• Plan and prepare eCTD and CTA submissions.
• Author regulatory documents.
• Lead teams developing responses to Agency requests for information and other queries.
• Coordinate all activities related to Health Authority meetings.
• Review submission documents and ensure adherence to regulatory requirements.
• Collaborate with Sr. regulatory leadership to develop regulatory strategies.
• Lead project sub teams and track timelines and deliverables.
• Collaborate with Regulatory Operations team to ensure all documents, submissions and communications are properly stored in RIM system.
• Assists with requests related to regulatory intelligence activities.
• Monitors regulatory guidances and update regulatory affairs team when any are updated by the FDA or ex-US health authorities.
• Provides updates on industry trends and observations.
• Educates regulatory affairs and company on regulatory requirements.

• 5+ years experience within the pharmaceutical, biotechnology or device/diagnostics industry.
• Proficient in authoring of regulatory documents
• Knowledge of regulatory guidances
• Experience submitting electronic submissions to Health Authorities (e.g., FDA, EMA, etc.), with in depth knowledge of all aspects involved with eCTD applications including post approval submission requirements.
• BS/MS preferably in a scientific field or information technology field.
• Proficient with relevant submission software, including but not limited to, Veeva Submissions, Adobe Acrobat, ISIToolbox, Microsoft Office, eCTD viewers.
• Ability to work calmly within a fast-past environment, under short deadlines, and to cope with last minute changes.
• Highly organized and detail oriented.

Work Environment:

The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

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