REGULATORY PHARMACIST

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.

Proof-read 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 labelling 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.

Other related task that may be assigned.

Job qualifications:

Bachelors degree in Pharmacy.

Must be a licensed Pharmacist.

At least three (3) years experience in a pharmaceutical firm is an advance but not required.

Fresh Graduates are encouraged to apply

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

Ability to handle multiple projects.

Good moral character.

Willing to work in Bancal, Carmona Cavite

Working schedule will be from Mondays to Friday

Summary of role requirements:

Flexible hours available

2-3 years of relevant work experience required for this role

Working rights required for this role

Expected start date for role: 16 April 2024

Full time