Regulatory Affairs Associate

Industry Category	Healthcare	Position	Pharmacy
Recruitment Department		Number Of Recruits	several
Work Location	All Cities	Nature Of Work	Full Time
Gender Requirements	Male	Marriage Requirement	No marital status restrictions
Education Level	College Diploma	Work Experience	No work experience restrictions
Age Requirement	Above 18 years old	Salary Package	Negotiable
Updated Date	2022-09-26	Valid Until	Long-term validity

The Regulatory Affairs Associate shall provide technical and logistic support to legal and registration activities of the Regulatory Affairs Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. 

Responsibilities:

Handle registration (review and submission) and monitoring of food and food supplements, cosmetics and medical devicesRepresent the company/ Act as liaison officer to the local FDA (for assigned products)Assist the RA Head in complying with the local FDA’s regulatory guidelinesProvide regulatory information through preparation of registration updates, maintenance and update of product information, registration dossiers and regulatory files; submission of updated prescribing information and other updates/ variations in technical information to FDA and includes monitoring of implementation; updating of all product monographs for publication in the local compendiaProvide technical support to internal and external customers including, but not limited to:

- prompt preparation and compilation of additional regulatory requirements in support of marketing thrusts and directions

- provision of updated Certificate of Product Registration to business units for inclusion in drugstores, hospital formularies and bidding purposes

-accomplishing regulatory reports for submission to RA Head

-assist in the management of regulatory tools and database

Act as local QPPV (Qualified Person Responsible for Pharmacovigilance)Perform other job-related duties and responsibilities as determined by RA Head and/or job-related tasks as needed by the company

Qualifications:

Bachelor’s/ College Degree in Pharmacy (duly registered with the Professional Regulation Commission)At least 1-2 years of working experience in regulatory affairs and in the pharmaceutical industryExperience in handling Food/ Food Supplements, Cosmetics and Medical Devices is an advantageMust have good communication skills (both oral and written) and able to work independently or with very minimal supervision.