Regulatory Pharmacist

Suhitas Pharmaceuticals Inc.; Makati; Hybrid; PHP 600,000 - 800,000; Full time

Job summary

A leading pharmaceutical company in Makati is seeking a Regulatory Affairs Pharmacist. The role involves managing product registration, ensuring compliance with FDA regulations, and conducting reviews of product labels. The ideal candidate should have a Bachelor's degree in Pharmacy and 3-5 years of experience in regulatory affairs. This position may offer potential for remote work and requires attention to detail and strong organizational skills.

Qualifications

• Licensed Pharmacist with 2-3 years of related experience in the related field.
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission procedures.
• Strong understanding of drug development, manufacturing processes, and quality standards.

Responsibilities

• Responsible for the company’s LTO application, renewal and variations.
• Handle product registration processes for Drugs, Medical Devices, Foods, Cosmetics.
• Prepare submissions of renewals of CPR’s, monitor deadlines and ensure timely submission.
• Conduct thorough reviews of product labels for compliance with FDA regulations.
• Monitor and encode Electronic Drug Price Monitoring System (EDPMS) by the DOH.

Skills

Regulatory guidelines understanding

Communication skills

Critical thinking

Attention to detail

Organizational abilities

Education

Bachelor’s degree in Pharmacy or a related field

Job description

Overview

REGULATORY AFFAIRS PHARMACIST

Responsibilities

• Responsible for the company’s LTO application, renewal and variations.
• Responsible for handling product registration processes for Drugs, Medical Devices, Foods, Cosmetics including reviewing and preparing documentation and applications for submission to the FDA. Ensuring completeness, accuracy and adherence to regulatory guidelines.
• Prepare submissions of renewals of the CPR’s, monitor deadlines and ensure timely submission.
• Prepares submissions and communicate with distributors during the processing of CLIDP’s applications.
• Handles amendments / variations applications.
• Conduct thorough reviews of product labels (both primary and secondary packaging) for initial, CLIDP’s and renewal, verifying compliance with FDA labeling regulations, and proofreading all label content for accuracy and consistency before commercialization.
• Maintain a proactive follow-up with the FDA to track application status.
• Communicate with principals (manufacturers) regarding regulatory compliance, product issues, or clarifications needed for registration or variation processes.
• Ensure the company's Standard Operating Procedures (SOPs) are up-to-date and aligned with the latest FDA regulations, conducting regular reviews and updates, and maintaining proper documentation for audit and compliance purposes.
• Responsible for monitoring and encoding of Electronic Drug Price Monitoring System (EDPMS) by the (DOH).
• Oversee the management of product-related concerns, including handling customer complaints, coordinating product recalls and withdrawals, and managing product distribution and returns within the subsidiary's scope of operations.
• Responsible for managing IPO applications and handling all related tasks and activities.
• Manage and securely maintain all documentation, including Certificates of Product Registration (CPRs) and Licenses to Operate (LTOs), ensuring their proper storage, accessibility, and confidentiality.
• Perform other duties as assigned by superiors.
• Ensure compliance with regulatory requirements for drug products.

Qualifications and Requirements

• Educational Qualifications: Bachelor’s degree in Pharmacy or a related field.
• Experience Level: 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• Skills and Competencies: Strong understanding of regulatory guidelines, excellent communication skills, and critical thinking ability.
• Working Conditions: Office environment with potential for remote work; may involve occasional travel.
• Qualities and Traits: Detail-oriented, proactive, adaptable, and strong ethical standards.

Job Requirements

• Licensed Pharmacist with 2-3 years of related experience in the related field
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission procedures.
• Strong understanding of drug development, manufacturing processes, and quality standards.
• Excellent communication and interpersonal skills.
• Attention to detail and strong organizational abilities.
• Ability to interpret and analyze regulatory documents and data.

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