Regulatory Affairs Assistant

Position Title: Business Development and Regulatory Affairs Assistant

Responsibilities:

• Assist in providing scientific and medical information to help the Company create a product pipeline.
• Assist in conducting market and product research to identify new products and opportunities for the Company.
• Assist in sourcing of manufacturers and other suppliers needed for launching new products.

• Coordinates registration requirements with the suppliers.
• Assist and evaluates the requirements of Certificate of Product Registration (CPR) and other FDA authorizations.
• File, monitors and closely follow up applications with the FDA.
• Monitor and maintain the validity of CPR’s, LTO’s, and other permits.
• Register and maintain the the validity of trademarks with the Intellectual Property Office.
• Generate and maintain product barcodes.
• Request and monitor labeling exhaustion of all products.
• Assist in maintaining and keeping the records of all regulatory-related documents such as Agreements with suppliers, FDA Licenses for local suppliers, GMP Certificates for foreign and local suppliers, Adverse Drug Reaction Reports, Product Complaints, Product Recall, Batch Notifications (for antibiotics), Lot Release Certificates (for vaccines).
• Responsible for receiving complaints from customers through letter, email, or by hand.
• Provide related documents needed for hospital inclusion, institutions, special accounts, and others.
• Assist in reviewing and updating Standard Operating Procedures (SOP) and Risk Management Plan (RMP) yearly.
• Assist in reviewing marketing collaterals for approval.

Qualifications:

• Male/Female
• Graduate of Bachelor of Science in Pharmacy
• Registered Pharmacist
• With at least 2 years experience in any Pharmacy setting
• With technical and regulatory knowledge is an advantage
• Has good interpersonal skills
• Organized and attentive to detail

What we can offer:

• Very innovative and highly dynamic organization
• High achieving, driven, experienced team
• Competitive and above industry compensation package
• Fun and homelike work environment
• The chance to be part of a rapidly growing startup and the next success story

Benefits (upon hiring or regularization) :

• HMO
• Group Life Insurance
• Free Lunch
• Transportation Allowance
• Communication Allowance
• VL & SL
• OPD Medical Reimbursement
• Optical Reimbursement
• Clothing Allowance / Company Uniform