Regulatory Affairs Associate Manager

Pharmaceuticals & Medical Devices (Healthcare & Medical)

• Candidate must possess at least Bachelor's/College Degree in Pharmacy/Pharmacology or equivalent.
• At least 3-5 Year(s) of working experience in the Pharmaceutical industry or related field is required for this position.
• Preferably Supervisor/ Assistant Manager specialized in Healthcare - Pharmacy or equivalent.
• Licensed Pharmacist is a must

ROLES:

• Reviews, prepares and submits application for Initial registration of assigned partner products.
• Updates local Regulatory database with issued LTOs, CPRs, FDA submissions and releases, soft copies of submissions, document management for documents provided by Regional RA and Partners.
• Designated Authorized Pharmacist for PDEA
• Coordinates and provide regulatory guidance to internal stakeholders, Regional Regulatory Counterpart and assigned principals on registration requirements.
• Acts as the local complaint coordinator; coordinates with Regional QA on complaints related to Regional and Corporate brands, with partners for agency products.
• Maintenance of PDEA and Cosmetics License to Operate to support the business.
• Conducts training on Regulatory Associate/project-based employees on registration requirements, artworks and Regulatory database.

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