76 Regulatory Affairs Specialist jobs in the Philippines

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

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

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

At Getz Pharma, our mission is to make a global impact by developing and delivering safe, effective, and high-quality medicines that improve the lives of men, women, and children.

Be part of a company where your work directly contributes to better health outcomes and a healthier world.

Why Join Getz Pharma as a Senior Regulatory Affairs Specialist?

Drive Regulatory Excellence and Compliance

• Lead the preparation, review, and submission of regulatory dossiers for product registrations, variations, and renewals.
• Act as the primary liaison with the FDA and other health authorities, ensuring timely responses and positive relationships.
• Monitor evolving regulatory guidelines and communicate their impact to internal stakeholders.

Support Cross-Functional Teams to Deliver Better Medicines

• Provide regulatory guidance to R&D, Quality, Supply Chain, Marketing, and Medical Affairs teams.
• Ensure product labeling, promotional materials, and packaging meet all regulatory requirements.
• Collaborate across departments to integrate regulatory strategies into product development and lifecycle management.

Lead Regulatory Strategy and Product Lifecycle Management

• Drive regulatory strategy for assigned products to achieve timely approvals.
• Ensure product registrations are maintained and renewed without disruption.
• Participate in audits and inspections, ensuring compliance with both local and international standards.

Mentor and Share Expertise

• Guide and train junior Regulatory Affairs team members on processes, best practices, and compliance.
• Share insights on regulatory updates and industry trends to strengthen team capability.
• Take ownership of additional responsibilities in a dynamic, fast-paced environment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field (Master's degree preferred).
• 4-5 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of FDA, ASEAN, and ICH guidelines.
• Proven experience in preparing and submitting regulatory dossiers.
• Excellent communication, project management, and organizational skills.
• Ability to work cross-functionally and manage multiple priorities.

The Regulatory Affairs Senior Specialist supports the preparation and submission of regulatory documents, ensuring compliance with local and international pharmaceutical regulations. The role involves liaising with regulatory authorities to ensure timely approvals and maintaining regulatory compliance for pharmaceutical products.

Technical Skills:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities.
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

1. Regulatory Submissions:

Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.

Liaise with regulatory authorities to follow up on submissions and address queries or deficiencies promptly.

2. Documentation Management:

Organize and maintain regulatory files, records, and databases to ensure accurate tracking of submissions and approvals.

Ensure all regulatory documentation is complete, accurate, and compliant with relevant guidelines.

3. Compliance Monitoring:

Monitor updates in regulatory requirements and guidelines and assist in implementing necessary changes.

Review labeling, packaging, and promotional materials to ensure regulatory compliance.

4. Cross-Functional Support:

Collaborate with internal teams (e.g., Quality, Manufacturing, Marketing) to gather required documents and data for regulatory purposes.

Provide regulatory support during product development and lifecycle management.

5. Communication with Authorities:

Serve as a primary contact for regulatory authorities, ensuring effective communication and addressing regulatory concerns.

Maintain strong working relationships with key stakeholders in regulatory agencies

Job Types: Full-time, Permanent, Fixed term

Pay: Php40, Php60,000.00 per month

Benefits:

• Paid training
• Pay raise

Education:

• Bachelor's (Preferred)

License/Certification:

• Licensed Pharmacist (Required)

Work Location: In person

The 
Regulatory Affairs Senior Specialist – Partnered Product
 manages the regulatory, quality and compliance aspects of partnering activities, ensuring smooth transitions and compliance for in-licensed and out-licensed products.

Qualifications:

• Licensed Pharmacist
• At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities, preferably with experience with in-licensing and out-licensing
• With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).

Key Responsibilities:

1. 
Due Diligence and Assessment

• Evaluate regulatory dossiers of in-licensed products for compliance and market readiness
• Conduct risk assessments for out-licensed products in collaboration with partners

2. 
Regulatory Submissions

• Support the registration of in-licensed products by reviewing and compiling required documentation.
• Prepare regulatory packages for out-licensed products to met partner and local requirements

3. 
Partnership Coordination

• Act as the primary regulatory contact for in-licensing and out-licensing partners
• Ensure timely updates and compliance with contractual obligations related to regulatory matters

4. 
Regulatory Intelligence

• Monitor regulatory landscapes in key markets to support licensing decisions
• Provide input on regulatory feasibility and timelines during partnership negotiations

5. 
Renewals and Life-cycle Management

• Manage lifecycle activities like renewals, variations, and periodic reporting for licensed products
• Ensure alignment with the partner's and authority's requirements for partnered products

6. 
Documentation and Communication

• Maintain detailed records of in-licensing and out-licensing regulatory agreements
• Prepare clear, concise reports for internal and partner updates

7. 
Quality Assurance and Compliance

• Collaborate with partners to ensure compliance with Good Manufacturing Practices (GMP) and quality standards o Review and assess quality agreements with in-licensing and out-licensing partners
• Support deviation management, change controls, and corrective actions related to partnered products
• Ensure quality compliance during product transfers, batch releases, and post-market surveillance
• Review marketing materials to ensure compliance with regulatory and global guidelines
• Ensure that promotional content aligns with local and partner market regulations
• Collaborate with internal teams and partners to address regulatory and global concerns in advertising and promotional strategies
• Monitor post-market promotional activities for compliance with regulatory standards

Job Title: Regulatory Affairs & Quality Manager

Work Location: Libis, Quezon City and Santolan, Pasig City (Onsite)

Work Schedule: Monday to Friday | 8:00 AM – 5:30 PM

Target Onboarding Date: ASAP

Employment Type: Full-Time | Onsite

Job Overview:

• We are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) Manager to oversee and implement company-wide quality systems and ensure strict compliance with regulatory requirements. This role is critical in managing internal audits, product quality, and documentation, while serving as the key liaison with regulatory agencies. Ideal for professionals with solid experience in highly regulated industries such as pharmaceuticals, cosmetics, food, or medical devices.

Key Responsibilities:

• Quality Systems Implementation: Develop and maintain quality control procedures, SOPs, and documentation.

• Regulatory Compliance: Ensure company operations meet local and international standards (FDA, ISO, GMP, etc.).

• Audit Management: Conduct internal/external quality audits and oversee third-party inspections.
• CAPA & Non-Conformance Management: Lead corrective and preventive actions and manage non-conforming products.
• Customer Complaint Handling: Investigate, document, and resolve product or service-related complaints.
• Vendor & Supplier Quality Oversight: Manage supplier qualification and monitor ongoing compliance with quality standards.
• Team Leadership: Supervise and mentor QA/RA staff; lead training programs on compliance and quality systems.
• Regulatory Submissions: Coordinate product registration, labeling, and other submissions to regulatory bodies.
• Data Analysis & Reporting: Analyze quality metrics and prepare regulatory reports for senior management.

Qualifications & Skills:

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

• Experience:

• At least 5 years of progressive experience in QA/RA management in a regulated industry (e.g., pharmaceuticals, medical devices, food, cosmetics).

• Technical Knowledge: Solid understanding of FDA regulations, ISO standards, GMP practices, and product lifecycle requirements.
• Soft Skills: Strong leadership, critical thinking, documentation, and communication skills.
• Tools & Systems: Proficiency in MS Office, Quality Management Systems (QMS), and regulatory databases.

Compensation & Benefits:

• Monthly Salary: Up to ₱80,000
• Allowance: Communication allowance
• Bonuses: 13th Month Pay
• HMO: Provided upon hire