Regulatory Affairs Associate

2 days ago

Pasay, National Capital Region, Philippines Ambica International Corporation Full time ₱250,000 - ₱500,000 per year

A Regulatory Affairs Associate will work collaboratively with all members of Regulatory Department. He/ She acts a responsible person in filing regulatory documents submitted and received from FDA. He/ She will also be the one who will update Regulatory Reports in which he/she will regularly send to all members of Regulatory Department for their reference.

Job Responsibilities

  • Responsible in updating and ensuring the correctness of Regulatory Reports (Reg PCPR and CLIDP Status, GMP List, CLIDP Report, PCPR Report.) and ensures consistency with the Soft and hard copies.
  • Scans and updates the Regulatory Server for FDA submissions and received documents and responsible in ensuring that there will be no missing document.
  • Responsible in ensuring correct filing of all FDA hardcopy receiving to each assigned binder accordingly.
  • Responsible in ensuring correct filing of all application submissions to each assigned binder accordingly.
  • Replies to XD, Sales Coordinator and other department request for copies of Proof of submission for applications.
  • Checking and preparation of original documents, CPRs/CLIDPs, GMP, LTOs for endorsement to the Office of the President.
  • Assist in Assay test submissions
  • Accommodates documents, Cash and Check Requests of Pharmacists then will forward to Vice-President for approval.
  • Prepares Weekly Cash Requests for FDA submissions/payments.
  • Prepares Cash Request for other miscellaneous payments (e.g. Toll Fees, Parking fees etc) then will forward to Accounting Department.
  • Prepares and ensures correctness of liquidation for all FDA payments, Assay, Toll fees, Parking fee and other Regulatory department expenses and corporate credit card.
  • Responsible in forwarding and receiving documents for Notary from Legal Department.
  • Prepares and submits FDA application for Re-issuance.
  • Accommodates all approved request for pull-out of samples from Retention Room
  • Other tasks as assigned by Regulatory Affairs Managers and Head

Job Qualification

  • Preferably B.S. Pharmacy graduate or any 4-year Medical Allied course graduate.
  • Must have good written and spoken communication skills and ability to multitask as well as work independently and under pressure.
  • Meticulous and keen to details.
  • Proficient in Microsoft Office (MS Word, Excel, PowerPoint, Outlook), PDF (Nitro Pro, Adobe etc.).
  • Able to type fast and accurately.
  • With knowledge or familiarity with pharmaceutical terms/products
  • Exceptionally well organized and strong work ethics.
  • Highly self-motivated and committed to pursuing long term career
  • Fast learner

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