Michelle Mutuc Rph, Mba Email & Phone Number

Singapore

• Certificate of Product Registration initial, renewals & variations applications
• Submissions of Product Safety Updates
• FDA Registration Follow ups of pending applications

Makati, National Capital Region, Philippines

• License to Operate opening, renewal & variations applications
• Facilitates notification of cosmetic products
• Facilitates food products registration
• FDA Registration Follow ups & amendment applications

Parañaque, National Capital Region, Philippines

• Manage day-to-day operations of the company
• Register various products, do dossier evaluation, communicate with Company’s client, submit application and make necessary follow-ups with the Food and Drug Administration (FDA).
• Review and prepare necessary documents for submission to relevant regulatory agencies and attend to all queries from the Company’s client
• Coordinate with the Company’s Accounting Department in the preparation of Statement of Accounts (SOA) or billings to the Company’s client.

Mandaluyong, National Capital Region, Philippines

• Support Regulatory Affairs Lead to develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and.
• Support expediting product commercialization by ensuring that country’s registration requirements are fulfilled, and registration approvals are obtained as quickly as possible.
• Review, analyze, coordinate and provide feedback to Regulatory Affairs Lead in matters relating to new product submissions and post approval maintenance of products as required.
• Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulation plans across Pfizer’s portfolio.
• Support Labeling and Artwork change management activities for product in responsible portfolio to ensure compliance to information and implementation timelines.
• Review and approve consumer medicine information, packaging labels, promotional material and other documentation as required for regulatory compliance, when required.

Bonifacio High Street, Taguig City

• Gathering, preparing, reviewing, verifying, finalizing and submitting to the Food and Drug Administration all relevant requirements for product registration and securing appropriate certificates of.
• Advising the Company, providing it with supporting documents, and rendering such other assistance to the Company for the purpose of securing all necessary FDA approvals relating to the Company's business and operations
• Reviewing product labels, promotional and other materials and works related to products of the Company including any claims about the products

Ortigas, Pasig City

• License to Operate opening, renewal & inclusion of sources
• Facilitates notification of cosmetic products
• FDA Registration Follow ups & amendment applications
• Preparation of Product Information (PIF) for FDA audit

Malaysia

• Ensure compliance of registered pack Components against the implemented pack by:o Reviewing each pack Component against the registered information and track or highlight differenceso Reviewing the Components of each.

Ortigas, Pasig City

*Oversee the preparation and submission of documentary requirements related to securing the Certificate of Product Registration*Review the product dossier provided by the supplier/manufacturer and ensure their completeness, accuracy and compliance to the requirements of FDA*Facilitates License to Operate opening, renewals and amendments

Ortigas, Pasig City

• Provides strategic directions to the Regulatory Affairs team with regards product registration applications, notifications and all other permits or licesces pertaining to FDA requirements.
• Facilitates Initial/Renewal/Registration Applications/ Documentation including Amendments and CSP application at the FDA in coordiation with the PPC Regulatory Affairs Assistant Manager
• Provides up-to-date regulatory conditions in terms of product registration applications, proceedings, PFDA policy changes, relevant new requirements and/or procedures.
• FDA Registration Follow ups & amendment applications
• License to Operate application, renewal & inclusion of sources
• Work with the Regulatory Affairs team in the achievement of the Team's targets

Makati City

• Preparation of Product Information (PIF) for FDA audit
• Assistance of Regulatory Officers during Inspection
• Renewal of License to Operate
• New Product Registrations
• Check/approve labeling materials
• Oversee Quality Assurance activities performed by the local repacker

Makati City

• License to Operate as Medical Device renewal & inclusion of sources
• Facilitates Initial and Renewal Registration of Medical Device Applications/ Documentation including Amendments and Compassionate Special Permit applications
• FDA Registration Follow ups & amendment applications

Makati City

• Liaise with the local Health Authorities on matters pertaining to regulatory activities, licenses and permit
• Ensure compliance with basic company and health authorities’ requirements and timeline by monitoring and tracking all company registrations and licenses.
• Check/approve packaging materials for development of new products
• Identify sources of regulatory difficulties and provide recommendation for resolution
• FDA Registration Follow ups & amendment applications