Heather Reed
Regulatory Operations Manager @Xgen Pharmaceuticals Djb
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WORK HISTORY
Regulatory Operations Manager @Xgen Pharmaceuticals Djb
Horseheads, NY, US
Manages overall activity of the department and directly supervises assigned personnel as follows: Assists in the selection of new personnel as appropriate. Reviews employee performance on a regularly scheduled basis. Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans. Conducts regular meetings and provides guidance and direction to personnel. Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing. Organizes, schedules, prioritizes and distributes workload among assigned personnel. Keeps personnel informed of pertinent policies and procedures affecting the department Administers personnel policies and procedures as established by company policy.• Serves as Administrator of the electronic Common Technical Document (eCTD) publishing tool and related systems. Collaborates with regulatory submission content contributors, regulatory leads and submission program management in the planning and preparation of eCTD submission components.•Coordinates the preparation and submission of ICSRs for all applicable ADEs received(15-day expedited and non-expedited) in the appropriate format via FDA’s Safety Reporting Portal in accordance with federal requirements, guidance documents, and internal procedures.•Manages State Licensing activities required for obtaining and maintaining proper licensure related to the wholesale distribution of pharmaceutical products (i.e, U.S. states, District of Columbia, Puerto Rico). • Monitors and investigates changes in the regulatory environment through direct interaction with regulatory agencies, attendance at trade seminars, routine review of the federal register, FDA Internet updates and other trade publications to assess the impact on internal operations preparation/submission platforms, in accordance with federal requirements, guidance documents.
EDUCATION
University of Scranton
Bachelor of Science (BS), Biochemistry
SKILLS
ABOUT HEATHER REED
Experienced Regulatory Affairs with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Vaccines, Regulatory Requirements, Biopharmaceuticals, and Purification. Strong legal professional with a Bachelor of Science (BS) focused in Biochemistry from University of Scranton.
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