Regulatory Affairs Manager

Basic Function

Leads team to support department objectives such as on-time renewal of registrations and licenses, proper documentation and filing of applications and technical dossiers, and timely approval of initial submissions.

About the Role

Implements strategic directions as defined by Research and Development/Regulatory Division Manager. Assesses and provides action plan to address regulatory issues of clients and company.

This position seeks to prepare complete and correct technical dossiers to fulfill regulatory requirements and provide registration dossiers promptly to fulfill client's requests.

The scope of this position also entails coordination with the different departments on all the aspects of product registration until it is approved by the regulatory agency; as well as coordinating with clients and different government agencies regarding product registration requirements. The position also provides regulatory updates so as the company is up to date on all government regulations.

Responsibilities

• Performs, monitors tasks, and ensures timely availability of deliverables expected from the Regulatory team.
• Checks technical dossier for product registration of export and local clients.
• Coordinates product registration activities with Interphil's different departments - Technical Services, Quality Control, Formulation Group, and Marketing.
• Strengthens regulatory compliance, both local and abroad, by submitting complete and correct technical dossiers on time.
• Seeks approval of product registration application from regulatory agency.
• Coordinates with client Regulatory Affairs Manager counterpart in preparing technical dossiers for product registration of local and export clients.
• Provides assistance to Accounts Manager, TSD, and R&D on FDA regulations.
• Keeps a live data of registration requirements of Asia and the Pacific.
• Acts as Pharmacovigilance officer

Qualifications

Education

College Education with BS Pharmacy/BS Industrial Pharmacy and passed the Government Licensure Examination.

Experience

Minimum of 5 years relevant work experience in Product Registration work in manufacturing industry preferably in Pharmaceutical, Food, and Cosmetics.

Required Skills

• Must be familiar with FDA and other government related regulatory requirements and product registration.
• Must have keen eyes for details.
• Must have a basic knowledge of computer operation
• Must have excellent communication skills