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 course college 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
Job Types: Full-time, Permanent, Fresh graduate
