Corporate Pharmacist -Regulatory

GENERIKA Drugstore; Parañaque; On-site; PHP 550,000 - 750,000; Full time

Job summary

GENERIKA Drugstore in the Philippines seeks a Corporate Pharmacist - Regulatory to liaise with FDA and DOH, ensuring store compliance and licensing.

You will coordinate LTO applications, license renewals, and submissions, review housebrand and product requirements, and keep up to date with regulatory changes.

Qualifications

• Bachelor’s degree in Pharmacy and licensure as a pharmacist.
• 2–3 years of relevant experience in pharma or drugstore operations.
• Experience in regulatory work with FDA/DOH is preferred.

Responsibilities

• Coordinate with Generika stores and distribution centers on LTO with FDA.
• Prepare license variations and renewals by strict deadlines.
• Develop arguments for new licenses and renewals.
• Monitor timelines for license variations and renewal approvals.
• Provide monthly LTO status reports.
• Consolidate and check promo requirements to FDA from multiple departments.
• Keep up to date with national and international regulations.
• Review and update Generika Gamot Guide and product requirements.
• Review Housebrand Artworks vs FDA requirements and EDPMS updates.
• Communicate FDA updates to relevant teams.

Skills

Regulatory Knowledge

Critical Thinking

Writing Skills

Oral Communication

Business Skills

Education

Bachelor's / College Degree in Pharmacy

Job description

JOB PURPOSE:

• The Corporate Pharmacist - Regulatory shall act as a liaison officer between the company and government agencies, such as the Food and Drug Administration (FDA) and Department of Health (DOH).
• The Corporate Pharmacist - Regulatory shall lead the compliance of all Generika stores with the requirements of FDA and DOH.

SUMMARY OF RESPONSIBILITIES:

1. Directly coordinates with the Generika stores, Actimed Distribution Centers, and prepare all requirements for license-to-operate (LTO) application with FDA
2. Prepares submissions of license variations and renewals to strict deadlines.
3. Develops and writes clear arguments and explanations for new licenses and license renewals.
4. Monitors and sets timelines for license variations and renewal approvals of all stores (GENERIKA DRUGSTORE) and distribution centers (ACTIMED).
5. Provides a monthly status report of the LTOs that may include initial, renewal and on-going applications.
6. Coordinates, consolidates, and checks the requirements for promo application to FDA from the applying departments (i.e., DKAG, TPM, RPU, and Marketing).
7. Keeps up to date with national and international legislation, guidelines, and customer practices.
8. Review and update Generika Gamot Guide.
9. Review and approval of Housebrand Artworks vs FDA requirements.
10. Review and approval of new product requirements.
11. EDPMS updates.
12. Review and cascade of FDA emerging products/memo.

JOB REQUIREMENTS:

EDUCATION & EXPERIENCE:

• Bachelors / College Degree in Pharmacy
• Registered Licensed Pharmacist
• At Least 2-3 years relevant experience in the pharmaceutical industry or drugstore operations
• Experience in regulatory work with government agencies particularly with FDA, DOH, etc.

COMPETENCIES:

• Regulatory Knowledge: Basic theoretical knowledge on legislation governing products and licenses and understanding technicality involved would be an advantage.
• Critical Thinking: Keeping close track to regulatory changes and interpreting its implications on the drug development and authorization process is part and parcel of life in regulatory affairs. RA professionals need to be able to synthesize basic information and convert it in a comprehensible manner especially during project team meeting.
• Writing Skills: Can support due diligence reviews, review of protocols, reports and all basic regulatory documentation with regards to quality, safety, and efficacy. While most regulatory documents are highly structured templates, it still requires a certain amount of linguistic skills to combine subject matter knowledge and information from a spectrum of regulatory guidelines in order to come up with a document that is in conformance with legal requirements.
• Oral Communication: Speaking clearly and persuasively in all possible situations. Being an effective communicator may come in handy in establishing relationship with regulatory authorities, marketing department, manufacturing sites and other relevant technical functions
• Business Skills: It is increasingly vital for RA professionals to also develop business skills and be able to integrate regulatory knowledge into business strategy. At the higher level of the career ladder, RA professionals have to exhibits sound judgment in finance, marketing and policy as well as making timely regulatory intelligence, guidance and strategy for the company.