348 Regulatory Intern jobs in the Philippines

The Regulatory Affairs & QA Specialist is responsible for assistance and support in ensuring Company's consistent compliance with Company and Philippine government and corporate standard regulatory and QA compliance.

II. PRINCIPAL DUTIES AND RESPONSIBILITIES (Brief but specific list of the major tasks, responsibilities, major projects, decisions, etc. of this position.)

Regulatory Affairs

1.Maintains good and harmonious professional relationship with government regulatory agencies.

1. Secures the required documents and materials from Global Regulatory Affairs, other Company affiliates and local R&D needed for obtaining local registration of products for line extension, reformulations, new sourcing and shelf-life extension.

2. Maintains an organized and secure filing and retrieval system of pharmaceutical regulatory affairs documents.

3. Obtains and renews necessary Government licenses, product registrations and permits for Company to legitimately operate as importer, distributor and trader as well as exporter.

4. Ensure the most timely and optimal approvals of Company products to market with compliance to government regulations.

5. Represent the department on global and local project teams, as requested.

6. In conjunction with the Artwork Coordinator, coordination and checking of product literature, label and other packaging component in artwork preparation

7. Will also work closely with technical colleague on timely response on pharmacovigilance report and feedbacks

8. Manage proper documentation and closure on any Change Notification

9. Prepare artwork for Company's products,e.g., labels, package inserts and other commercial facsimile presentations as per BAI/FDA requirement.

Marketing Services

Provide support to marketing colleagues with regards to new products information for MAR creation and approval and registration status for estimated date of product launching.

Technical Services

Provide support to the TSMs with regards to product information and other matters to product specifications.

QA/Quality Assurance

1.Evaluation of product registration/dossier for Product Releases to ensure that regulatory commitments are being met.

1. Responsible for the finished goods release of Company products before it is commercialized

2. Assistance in handling of product complaints (includes evaluation of investigation and closure of corrective actions)

3. Provides detailed Quality Oversight to third party distributor. QA/technical support for temperature mapping and packing transport studies for cold chain products, ultra-low/freezer items and those under liquid nitrogen

4. Handling Product Deviations

5. Conducts training as necessary on implementation of quality systems.e.g PV works.

6. Assist the Global Company Auditors in the conducts of Quality Systems audit of third-party manufacturer and distributor

7. Prepares SOP on Quality Systems, as necessary.

8. Helps in developing raw and packaging material sourcing.

9. Manages Quality Agreement of all the contractors and suppliers of the Company

10. Quality oversight for stickering activities at accredited third-party manufacturer.

Organization Development

1.Develops personal performance objectives and strategies on tasks to ensure implementation and successful achievement of all plans.

1. Actively participates and contributes to the development and accomplishment of the department's objectives.

2. Formulates, together with the immediate supervisor, individual performance objectives to enhance job knowledge, technical skills and overall effectiveness on the job.

3. Promotes and enhances professional working relationship with colleagues, superiors and with FDA, BAI or other external service agencies as necessary on matters of mutual concern.

4. Performs any other duties as assigned by immediate by superior.

QUALITY ASSURANCE:

• Responsible for the final release of products in the absence of Sr. RA/QA Manager.
• Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards
• Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
• Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
• Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.
• Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
• Participate in all regulatory, third party and customer audits and inspections, and corrective action response.
• Perform other duties as directed by the RA/QA Department management.
• Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.
• Document quality assurance activities with internal reporting and audits.

REGULATORY AFFAIRS:

DOCUMENTATION

• Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.
• Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.
• Reviews Standard Operating Procedure based on the actual activity.
• Ensures that all pertinent documents for Cosmetic are available for FDA inspection.
• Compiles and maintain complete technical data of each product by timely update of LTO's master file
• Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.

OPERATIONS

• Ensures that formulation conforms to FDA standards and is within the approved limit.
• Ensures that labels of new and existing items conform to ACD Standards.
• Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.
• Generates barcode and monitoring of registration on-line.
• Ensures that RGDI warehouses are complying with FDA requirements.
• Assists FDA inspector with the needs during inspection and makes sure that company is compliant.
• Conducts product tests for all finished goods distributed and imported by the company.
• Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.
• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
• Coordinates the schedule of pest control in Marilao.

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.
• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

Qualifications:

• Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least one (1) year work related experience in regulatory and/or QA field.
• At least 1 year of experience in a supervisory or team lead role.
• Familiarity with Philippine FDA processes, portals, and documentation.
• Strong understanding of local and international regulations on cosmetics and wellness products.

Job Type: Full-time

Benefits:

• Company events
• Health insurance
• Opportunities for promotion
• Promotion to permanent employee

Work Location: In person

QUALITY ASSURANCE:

· Responsible for the final release of products in the absence of Sr. RA/QA Manager.

· Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards

· Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.

· Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

· Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.

· Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.

· Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

· Participate in all regulatory, third party and customer audits and inspections, and corrective action response.

· Perform other duties as directed by the RA/QA Department management.

· Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.

· Document quality assurance activities with internal reporting and audits.

REGULATORY AFFAIRS:

DOCUMENTATION

· Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.

· Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.

• Reviews Standard Operating Procedure based on the actual activity.

· Ensures that all pertinent documents for Cosmetic are available for FDA inspection.

· Compiles and maintain complete technical data of each product by timely update of LTO's master file

· Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.

OPERATIONS

· Ensures that formulation conforms to FDA standards and is within the approved limit.

• Ensures that labels of new and existing items conform to ACD Standards.

· Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.

· Generates barcode and monitoring of registration on-line.

· Ensures that RGDI warehouses are complying with FDA requirements.

· Assists FDA inspector with the needs during inspection and makes sure that company is compliant.

• Conducts product tests for all finished goods distributed and imported by the company.

· Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.

• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
• Coordinates the schedule of pest control in Marilao

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.
• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

Qualifications:

• Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least one (2) year work related experience in regulatory and/or QA field.
• At least 1 year of experience in a supervisory or team lead role.
• Familiarity with Philippine FDA processes, portals, and documentation.
• Strong understanding of local and international regulations on cosmetics and wellness products.

QUALITY ASSURANCE:

• Responsible for the final release of products in the absence of Sr. RA/QA Manager.
• Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards
• Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
• Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
• Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.
• Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
• Participate in all regulatory, third party and customer audits and inspections, and corrective action response.
• Perform other duties as directed by the RA/QA Department management.
• Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.
• Document quality assurance activities with internal reporting and audits.

REGULATORY AFFAIRS:

DOCUMENTATION

• Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.
• Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.
• Reviews Standard Operating Procedure based on the actual activity.
• Ensures that all pertinent documents for Cosmetic are available for FDA inspection.
• Compiles and maintain complete technical data of each product by timely update of LTO's master file
• Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.

OPERATIONS

• Ensures that formulation conforms to FDA standards and is within the approved limit.
• Ensures that labels of new and existing items conform to ACD Standards.
• Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.
• Generates barcode and monitoring of registration on-line.
• Ensures that RGDI warehouses are complying with FDA requirements.
• Assists FDA inspector with the needs during inspection and makes sure that company is compliant.
• Conducts product tests for all finished goods distributed and imported by the company.
• Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.
• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
• Coordinates the schedule of pest control in Marilao.

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.
• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

Qualifications:

• Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least one (1) year work related experience in regulatory and/or QA field.
• At least 1 year of experience in a supervisory or team lead role.
• Familiarity with Philippine FDA processes, portals, and documentation.
• Strong understanding of local and international regulations on cosmetics and wellness products.

Job Type: Full-time

Benefits:

• Company events
• Health insurance
• Opportunities for promotion
• Promotion to permanent employee

License/Certification:

• PRC license (Preferred)

Work Location: In person

QUALITY ASSURANCE:

· Responsible for the final release of products in the absence of Sr. RA/QA Manager.

· Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality Standards

· Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.

· Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

· Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.

· Follow up with implemented programs (GMPs, Good Hygiene Practices, Cleaning and Sanitation, Pest Control, Equipment Calibration) to ensure compliance by all employees and other personnel in the repacking facility.

· Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

· Participate in all regulatory, third party and customer audits and inspections, and corrective action response.

· Perform other duties as directed by the RA/QA Department management.

· Maintain compliant and non-conformance processing through records and tracking systems, including root-cause analysis and corrective actions.

· Document quality assurance activities with internal reporting and audits.

REGULATORY AFFAIRS:

DOCUMENTATION

· Prepares and check submissions of License to Operate renewal and other inter-related regulatory correspondence with FDA.

· Timely monitoring of product, license, permit and other licenses for renewal and ensure that all FDA license, certificates, and permits are updated and valid.

• Reviews Standard Operating Procedure based on the actual activity.

· Ensures that all pertinent documents for Cosmetic are available for FDA inspection.

· Compiles and maintain complete technical data of each product by timely update of LTO's master file

· Prepares, compiles, and maintains up-to-date Product Information Files (PIF) in compliance with ASEAN Cosmetic Directive requirements and ensures their availability during audits or regulatory inspections.

OPERATIONS

· Ensures that formulation conforms to FDA standards and is within the approved limit.

• Ensures that labels of new and existing items conform to ACD Standards.

· Checking of e-Portal for newly approved CPNs. Download, file and update the Notifications Summary.

· Generates barcode and monitoring of registration on-line.

· Ensures that RGDI warehouses are complying with FDA requirements.

· Assists FDA inspector with the needs during inspection and makes sure that company is compliant.

• Conducts product tests for all finished goods distributed and imported by the company.

· Maintain current knowledge of relevant regulations in Cosmetic and keeping up to date with changes in regulatory legislation and guidelines.

• Assists in updating related departments and regulatory head on latest regulatory requirements and FDA advisories.
• Coordinates the schedule of pest control in Marilao

SUPPLIERS

• Monitoring in conducting annual audits of all active suppliers.
• Coordination with manufacturers for Product Information File for filing based on ASEAN Cosmetic Directive.
• Processing of initial and renewal of agreements and request for updated GMP and ISO of all active suppliers.

Qualifications:

• Graduate of Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least one (2) year work related experience in regulatory and/or QA field.
• At least 1 year of experience in a supervisory or team lead role.
• Familiarity with Philippine FDA processes, portals, and documentation.
• Strong understanding of local and international regulations on cosmetics and wellness products.

About the Role

This position involves managing regulatory submissions, maintaining compliance documentation, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will possess strong knowledge of regulatory affairs, attention to detail, and the ability to navigate complex regulations in the pharmaceutical, biotechnology, or medical device industries. This is an excellent opportunity for someone who thrives in a dynamic, fast-paced environment and is eager to contribute to product development and market access.

Responsibilities

• Perform various functions pertinent to preparation of regulatory documents and documents for product registration.
• Maintain current knowledge of relevant regulations, including proposed and final rules to ensure compliance with regulatory standards and guidelines
• Represent the company for FDA transactions and registration of products. (CDRRHR and CCRR)
• Perform liaison activities at the Food and Drug Administration, IPO and other agencies.

Qualifications

• Graduate of Bachelor of Science in Pharmacy/ Licensed Pharmacist
• In-depth knowledge of regulatory guidelines and standards in the industry
• At least 1-2 years of working experience in the related field is required for this position
• Excellent written and verbal communication skills
• Detail-oriented with strong organizational and analytical skills

• Graduate of BS Pharmacy
• Must be aRegistered Pharmacist
• Must have 1-3 years of experience dealing with FDA and Regulatory Affairs
• Ensures that all the necessary marketing authorizations are secured and up-to-date prior to operation and/or distribution of products.
• Responsible for knowing the most current applicable regulations that affect the Cosmetic and Drug Industry to ensure that the products that are distributed by the company are in accordance with the current national standards and regulation.
• Strong analytical skills, good planning & execution, and verbal communication.

Job Type: Permanent

Benefits:

• Additional leave
• Health insurance
• Life insurance

Ability to commute/relocate:

• Pasay: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Regulatory Affairs: 1 year (Preferred)

Work Location: In person

Responsibilities:

Deals with and takes care of regulatory issues and carries out the plan to make sure the company complies with regulations

Establishes procedures and systems to make sure that all required filings, certifications, and

permits are completed and kept track.

Collate, Prepare registration requirements and Liaise with respective regulatory agencies in

securing appropriate License and Product Registration.

Keeping up to date with changes in regulatory legislation and guidelines.

Documenting the product classifications that need regulations and protocols.

Ensures that company's products comply with the regulations of the regions where they should be distributed (BFAD, PEDEA, FDA, CNDM, PMPIN, etc.)

Prepares and submits applications and reports to applicable regulatory agencies.

Ensures that quality standards are met and submissions meet strict deadlines

Remain current with regional, national, and worldwide laws, regulations, and consumer behavior

Examines business practices and procedures and offers suggestions for system improvements

Coordinates and liaises for timely, effective, ethical, and strategic adherence to local regulatory requirements

Assures orderly filing, thoroughness, confidentiality, adherence to the companies' standards, and readiness for local audits.

To review, analyze, prepare and assemble regulatory documents needed per shipment.

Ensures product information, permits and licenses are updated and accessible.

Assisting the IMPEX on the shipments related concerns

Maintain the updated files of product registration and regulatory compliance documents.

Coordination with the the ImpEx Officer.

Secure licenses and certificate of the company. (e.g., BOC Permit, BFAD, FDA, etc.,)

Ensure that quality standards are met and submissions meet strict deadlines.

Performs other related duties as required and assigned.

Support Individual department heads on creation/update on their SOP and Policies.

Qualifications:

Graduate of BS in Pharmacy or other related courses.

Relevant work experience is preferred but not required

Excellent written and verbal communication skills

Good coordination skills and keen attention to details

Must be a team-player and understands the role as part of a bigger group and knows how the job integrates with that of other teams and departments in achieving a common goal.

Proficient in MS applications

Attentive to detail and maintain an organized work environment.

Strong decision-making and leadership capability, and a team-player

Training & Certifications

Honest and trustworthy.

Can work under pressure with minimum supervision and with self-initiative

Amenable to work onsite in Alabang, Muntinlupa City

Job Type: Full-time

Work Location: In person

About the role

Reporting to the Head of Regulatory Affairs, this full-time Regulatory Affairs Officer position at Square Pharmaceutical, Inc' is a crucial role within the company's Science & Technology team. Based in Carmona Cavite, this role will be responsible for ensuring Square Pharmaceutical's products meet all relevant regulatory requirements and guidelines.

What you'll be doing

• Prepare and submit regulatory applications and documentation to governing bodies such as the FDA and EMA
• Monitor changes in regulations and guidelines, and advise the business on the impact and required actions
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
• Lead regulatory inspections and audits, and manage any resulting corrective actions
• Build and maintain strong relationships with key regulatory authorities
• Contribute to the development and implementation of the company's regulatory strategy

What we're looking for

• In-depth knowledge of global regulatory requirements and guidelines for pharmaceutical products
• Excellent written and verbal communication skills, with the ability to translate complex regulatory information
• Strong project management and problem-solving skills, with the ability to work independently
• Graduate of BS Pharmacy (licensed or not welcome to apply)

What we offer

• Dynamic, collaborative work environment with supportive colleagues

About us

Square Pharmaceutical, Inc' is a pharmaceutical company dedicated to developing and manufacturing high-quality medications. With a strong focus on innovation and quality, we are committed to advancing the standards of healthcare through our diverse portfolio of products and solutions.

If this role sounds like the perfect next step in your career, we encourage you to apply now.