Regulatory Affairs Officer

Facilitate timely applications of the products due for registrations (Initial / Renewal /
Amendments) including compliance to issued notice of deficiencies (NOD) by the regulatory agencies.

Ensure that ALL company licenses to operate are valid at all times.
Knowledgeable on transacting related regulatory applications with FDA, BAI
(VDAP/FEEDS), NMIS, BPI, BFAR, IPO and other regulatory agencies.

Coordinates and represents Hexagon Healthcare Corporation on all respective agency inspectors during routine inspections.
Ensure that all registered products being imported and offer for sale have the required retention quantity for the purpose of FDA inspection and possible quality ---------- tablish and monitor technical document filing system as well as department’s standard operating procedure (SOP), with relevance to receipt, storage/retention, distribution, returns and recall, and compliance to good storage and distribution practice ( GSDP).
Ensure compliance to GSDP by giving recommendations on its ---------- municates and coordinates to local traders/distributors with regards to their needs on technical and regulatory assistance such as regulatory requirements, regulatory updates, etc.
Attend to relevant regulatory trainings, seminar, convention and meetings.
Willing to be assigned as the officer of the day to receive and process service memo’s and coordination request/s, specifically requiring technical/ regulatory ---------- eck and review artwork / designs of products due for registrations for initial/amendment compliance application at respective regulatory agencies, as well as those registered.
QUALIFICATIONS

Education:
- Graduate of Bachelor of Science in Pharmacy , must be a Board Passer of the

Pharmacy Licensure Examination.

Skills
- Interpersonal, Communication and Presentation Skills

- Documentation and File management skills

- Facilitation and Negotiation skills

- Organizational and Coordination

- Computer literate, Knowledge on MS Office applications

Job Experience
- A regulatory work related experience expertise is a preference.