Regulatory PharmacistCompact Pharmaceuticals Corp

JOB DESCRIPTION
Serves as a link between the company and local regulatory authorities, ensuring compliance with FDA policies and guidelines and other government bodies.
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 regulatory policies. Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.
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 government-required lectures and seminars.
Manage and/or participate in the company's response to adverse event reports.
JOB QUALIFICATION
Degree holder or above in Pharmacy
Registered / Licensed Pharmacist with a valid practicing certificate in the Philippines.
One year of supervisory experience in Pharmaceutical manufacturing in a GMP environment is an advantage.
Less experienced applicants are welcome as comprehensive training will be provided.
Excellent command of spoken and written English
OTHER JOB REQUIREMENTS
Education
Bachelor's/College Degree
Field of study
Pharmacy/Pharmacology
Specialization
Manufacturing
JOB BENEFITS
Knowledge in MS Office, Communicating skills