Regulatory Compliance Officer

DUTIES & RESPONSIBILITIES

• Ensures that a company complies with all relevant regulations, especially for product registration
• Process License to Operate and Certificate of Product Registration at FDA
• Apply for a certificate of product registration to have their products examined and registered with the FDA
• Handle all the concerns of the products
• Negotiation & team-up with head office and local department
• Monitor and ensure that FDA regulations are followed, observed and complied
• Thorough review the product of registration of dossier before submitting in FDA
• Represent the company as an official liaison officer of the company
• Liaise with the local Health Authorities (i.e. FDA, , ETC)
• Act as the FDA -Registered Pharmacist and handle all regulatory-related transactions with FDA
• Coordinate with concerned business units and head offices in matters pertaining to the registration/concerns of existing and new products
• Prompt preparation and compilation of additional regulatory requirements in support of Marketing thrusts and directions
• Issue requested authenticated Certificates of Product Registration to business units for bidding/compliance purposes
• Preparation including request of payment for bidding purposes
• Perform other duties that are deemed necessary

REQUIREMENTS

• Must be a licensed Pharmacist
• Minimum of 3 yrs working in a Manufacturing/Pharmaceutical industry
• Required Skills: Fast learner, Good communication, Flexible, Driven and Results oriented.
• Preferably living within or near Sauyo, Quezon City

Job Type: Full-time

Schedule:

• 8 hour shift

Supplemental Pay:

• 13th month salary