145 Pharmaceutical Regulatory jobs in the Philippines

The Regulatory Affairs Specialist shall provide technical

support to legal and registration activities of the RA

Department in compliance to the regulatory requirements

as mandated by specific regulatory agencies.

The Regulatory Affairs Specialist is responsible for ensuring that all ORO Socks and Stockings and OMG Cosmetics products comply with government regulations and internal quality standards. This role manages product registration, regulatory documentation, and communication with relevant government agencies such as the FDA, DTI, and other certifying bodies. The position ensures that product labeling, claims, and formulations meet the necessary legal and industry requirements.

Key Responsibilities:

• Prepare, compile, and submit product registration dossiers to regulatory authorities (e.g., FDA, DOH, DTI).

• Monitor and ensure compliance of all products with applicable local and international regulations, including labeling and packaging requirements.

• Maintain and update regulatory documentation, including Certificates of Product Notification, Safety Data Sheets (SDS), and Technical Data Sheets.

• Coordinate with internal teams (R&D, QA, Marketing) to ensure regulatory requirements are considered in product development and launch.

• Review marketing materials, labels, and advertisements to ensure claims are substantiated and compliant.

• Liaise with regulatory agencies and act as the company's representative for audits and inspections.

• Keep the organization updated on regulatory changes, trends, and emerging compliance risks.

• Support product recalls or withdrawals by preparing documentation and coordinating with relevant teams and authorities.

• Assist in renewing business permits, licenses, and product certifications.

• Train internal staff on regulatory policies and changes as needed.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.

• At least 1–2 years of experience in regulatory affairs, preferably in cosmetics, personal care, pharmaceuticals, or FMCG.

• Knowledge of FDA regulations, ASEAN Cosmetic Directive, GMP, and product registration requirements.

• Familiarity with product formulation documentation, safety assessments, and labeling regulations.

• Strong organizational and documentation skills with high attention to detail.

• Good communication and interpersonal skills to effectively liaise with regulatory bodies and internal teams.

• Proficient in MS Office; experience in regulatory management systems is a plus.

• Willing to work in Balintawak, Quezon City, and can handle multiple regulatory projects simultaneously.

Job Types: Full-time, Permanent

Pay: Php18, Php20,000.00 per month

Application Question(s):

• How much is your expecting salary?

Education:

• Bachelor's (Preferred)

Work Location: In person

Regulatory Affairs Specialist:

• Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry
• At least 1 year exposure to Pharmacovigilance and FDA promo permit submission
• Knowledgeable in regulatory requirements for consumer health products
• Must be proficient in MS Word, Excel, and Outlook
• Detail oriented and with strong organizational and time management skills
• Highly flexible and adaptable to change

JOB OVERVIEW:

The Regulatory Affairs Specialist is responsible for managing all regulatory affairs, documentation, and follow-up transactions with the FDA and LGUs. He/She ensures that all company products comply with legislative requirements, secures and maintains updated permits and licenses, and oversees Grifols logistics.

TASK LIST:

• RA Compliance
• Permits & Licenses
• Product Documentation and Registration
• Grifols Logistic Oversight

QUALIFICATIONS:

• Graduate of BS Pharmacy; must be a Licensed Pharmacist
• At least 1 year as RA Specialist or Officer
• Knowledgeable in FDA QPIRA for Medical Devices, Regulations of LGU such as Mayor's Permit Sanitary, Fire, SEC, DDB, BOC, PhilGEPS and BIR ( Non-taxation transaction)
• Keen on details

OFFICE ADDRESS:

14A 3rd St. New Manila, Quezon City

Job Types: Full-time, Permanent

Benefits:

• Additional leave
• Company Christmas gift
• Company events
• Free parking
• Health insurance
• Life insurance
• On-site parking
• Opportunities for promotion
• Paid training
• Pay raise
• Promotion to permanent employee

Work Location: In person

Regulatory Specialist:

· Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry

· At least 1 year exposure to Pharmacovigilance and FDA promo permit submission

· Knowledgeable in regulatory requirements for consumer health products

· Must be proficient in MS Word, Excel, and Outlook

· Detail oriented and with strong organizational and time management skills

· Highly flexible and adaptable to change

Job Type: Full-time

Benefits:

• Company events
• Employee discount
• Flextime
• Health insurance
• Life insurance
• Paid training
• Work from home

Work Location: In person

Company Description

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Role Description

This is a full-time on-site role for a Regulatory Affairs Specialist located in Metro Manila. The Regulatory Affairs Specialist will be responsible for preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, coordinating regulatory submissions, and staying up-to-date with regulatory affairs. Additionally, this role involves liaising with internal departments and regulatory authorities to facilitate smooth submissions and approvals.

Qualifications

• Proficiency in Regulatory Documentation, and Regulatory Submissions
• Extensive knowledge of Regulatory Compliance, and Regulatory Requirements
• Experience with Regulatory Affairs processes
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work well under pressure and meet tight deadlines
• Bachelor's degree in Life Sciences, Pharmacy, or a related field
• Previous experience in the pharmaceutical industry is an advantage