Regulatory Pharmacist

Wellpro Biomedical Inc; Pasig; On-site; PHP 334,800 - 446,400; Full time

Job summary

A pharmaceutical company in the Philippines seeks a Regulatory Compliance Officer to handle FDA documentation, monitor application statuses, and ensure compliance. The ideal candidate has a Bachelor's Degree in Pharmacy and at least 2 years of experience in regulatory compliance, along with excellent communication skills.

Qualifications

• Bachelor's degree in Pharmacy or any medical field.
• At least 2 years of experience as Regulatory Compliance Officer.
• Detail-oriented with attention to accuracy.

Responsibilities

• Prepare and submit documents to the Philippine FDA.
• Monitor application status with the FDA.
• Create and review packaging layouts according to FDA standards.

Skills

Attention to detail

Excellent communication skills

Interpersonal skills

Education

Bachelor's Degree in Pharmacy or related field

Job description

Responsibilities

Your responsibilities will include:

• Prepares & submits documents to Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) & drug product - ACTD document for Initial registration, Site Registration/GMP Clearance applications, BA/BE study report, renewal of CPR, including variations and compliance of existing products.
• Must know or have an experience applying Initial and renewal application for drug products.
• Monitors the status of applications with the FDA.
• Creates and reviews packaging layouts in line with existing standards set by FDA.
• Handles company inspection and audit relevant to third party and government agencies.
• Handles applications with Intellectual Property Office (IPO) for trademarks and other functions of the agency.
• Directly reports to Regulatory Manager.

Qualifications

To be successful in this role, you will need to have:

• Bachelor’s Degree in Pharmacy or any related courses in Medical Field.
• At least 2 years of working experience as Regulatory Compliance Officer.
• Detail oriented and attention to accuracy.
• Excellent communication and interpersonal skills.