Job Description

• Ensure product, LTO, and other government permits and registrations are up to date and fully compliant.
• Compile registration dossiers for submission to FDA. Evaluate regulatory risk and strategy for proposed new products and ingredients. Manage, monitor, and safekeeping of FDA filings.
• Manage and/or participate in inspections of company facilities by FDA and other applicable agencies.
• Liaise with different departments to address regulatory issues that impact compliance.
• Provide regulatory input on product and packaging development. Proofread labels based on an understanding and interpretation of product formulas, contract provisions, account preferences, and, applicable regulation policies. Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.
• Bear license holder responsibility
• Participate in quality audits
• Keep the company up to date with changes in regulatory legislation and guidelines
• Provide information and training to concerned personnel with all matters relating to FDA regulations affecting product quality.
• Attend to government-required lectures and seminars
• Manage and/or participate in the company's response to adverse event reports.
• Perform Pharmacovilance Officer Functions: Ensures proper implementation and overall compliance to FDA mandated PV System through timely reporting when Adverse Events arise. Monitors record books and other related documentation and updates SOPs relating to Pharmacovigilance.
• Perform other related duties as assigned.

Skill/Knowledge & Other Requirements :

• Attention to detail and quality of documentation
• Good interpersonal,analytical and problem solving skills
• Effective oral and written communication skills
• Basic organizational and planning skills
• Ability to work independently with direction
• Working knowledge with FDA,PDEA, cGMP and GDP/ GSP principles is an advantage.
• Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products.
• Ability to handle multiple projects.
• Good moral character.

Job Qualifications:

• Bachelor's degree in Pharmacy.
• Professional License (Passed Board/Bar/Professional License Exam), Pharmacy/Pharmacology or equivalent IS REQUIRED.
• Has 1-2 years experience in pharmaceutical. (Fresh graduates are encouraged)

• Willing to work in Brgy. Bancal, Carmona Cavite.
• Can start ASAP.

Job Type: Full-timeSalary: From Php25,000.00 per monthSchedule:

• 8 hour shift

Ability to commute/relocate:

• Carmona, Cavite: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Regulatory Pharmacist: 1 year (Required)