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Regulatory Affairs Coordinator

2 months ago

Mastic Beach, New York, United States MyCareersFuture Full time
Job Summary

We are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at MyCareersFuture. As a key member of our Biopharmaceutical Group, you will provide administrative support to ensure the smooth operation of our Regulatory Affairs Department in Singapore.

Key Responsibilities
  • General Administrative Support
    • Provide a full range of administrative and secretarial support to the Biopharmaceutical Group Regulatory Affairs Department in Singapore.
  • Coordination of Meetings/Conferences/Trainings
    • Arrange and coordinate meeting/conference/training activities to ensure information on venue, time, and people is communicated in advance.
    • Coordinate with organizers on their meeting/training requirements and ensure the necessary room reservations and banquet arrangements.
    • Prepare and distribute meeting minutes when required.
  • Travel
    • Assist the HRA West ASEAN, local RA team, and overseas Pfizer colleagues (where required) to liaise with the travel agency or manage Pfizer global booking system (e.g. PT&E) to arrange air tickets, visa application (CIBT), itinerary, and book accommodation.
  • Correspondence
    • Assist in preparation of departmental communication letters and report preparation and coordination.
    • Sort and timely distribution of incoming mail/documents.
    • Ensure all outgoing mail is promptly attended by mail or courier.
  • Regulatory Support
    • Submission and tracking of ancillaries request for countries via CST to support in-country submission.
    • Policy: Supporting managers to coordinate and prepare relevant documents.
    • Preparation, coordination, and maintenance of compliance reports for relevant processes and systems.
    • Compassionate Use and Named Patient Basis Supply Local CMCD version update coordination.
    • Support Inspection Management.
    • Assist in Product defect reporting preparation.
    • Assist in preparing and coordinating Dear Healthcare Professional Letters (DHCPL).
    • Assist in Redressing specification document preparation and ordering of redressing material, where required.
    • Liaise with distributor on product destruction, where required.
    • Review signed order against Controlled Drug (CD) checklist.
    • Perform reconciliation of CD documentation periodically.
    • Assist with mailing of CD signed order to distributor.
    • Assist in ad-hoc regulatory affairs submission as necessary.