Regulatory Pharmacist - FDA Submissions & Compliance

RALCA Dev't. Corp.; Pasay; On-site; PHP 480,000 - 620,000; Full time

Benefits offered by this job

SSS, PhilHealth, Pag-IBIG

Lunch allowance ₱60 daily

Free shuttle service

HMO (upon regularization)

One free dependent with HMO

Paid leave

Quarterly incentives

Annual merit-based salary increases

Free staff accommodation (subject to条件

Job summary

Ambica Global is seeking a Regulatory Pharmacist to ensure FDA compliance and timely regulatory submissions in the Philippines. The role involves preparing, reviewing, and processing regulatory applications, product registrations, and supportive documentation across medicines, medical devices, food and cosmetics.

The candidate should be a licensed pharmacist with PRC, and able to coordinate with internal teams; fresh graduates are welcome.

Qualifications

• Must be a Licensed/Registered Pharmacist with a valid PRC license.
• At least 1 year of experience in Regulatory Affairs; fresh graduates are welcome.
• Familiarity with ACTD is an advantage but not required.
• Knowledge of FDA regulations, product registrations, and regulatory documentation is preferred.
• Strong written and verbal English communication skills.
• Proficient in computer applications with good typing speed and accuracy.
• Detail-oriented with ability to manage multiple regulatory submissions.

Responsibilities

• Prepare, evaluate, and submit regulatory documents for registrations and FDA-related applications.
• Ensure compliance of pharma, medical device, food, and cosmetics with FDA regulations.
• Process CPR, CLIDP, and LTO applications.
• Prepare technical documents per ACTD requirements.
• Handle GMP clearance applications and documentation.
• Coordinate with suppliers and internal teams for regulatory submissions.
• Monitor and follow up on FDA applications to secure timely approvals.
• Review labels, packaging, and artwork against FDA labeling standards.
• Evaluate technical and legal documents for accuracy and compliance.
• Maintain organized records of regulatory submissions and approvals.

Skills

Regulatory affairs

Documentation

Attention to detail

English communication

Project coordination

Analytical skills

Education

Licensed Pharmacist with PRC license

Job description

Ambica Global is seeking a Regulatory Pharmacist to ensure FDA compliance and timely regulatory submissions in the Philippines. The role involves preparing, reviewing, and processing regulatory applications, product registrations, and supportive documentation across medicines, medical devices, food and cosmetics.

The candidate should be a licensed pharmacist with PRC, and able to coordinate with internal teams; fresh graduates are welcome.