124 Regulatory Affairs jobs in the Philippines

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.

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.

About the role

As the Regulatory Affairs Manager at Macleods Pharmaceuticals Philippines Inc, you will play a crucial role in ensuring the company's compliance with all relevant regulations and guidelines within the pharmaceutical industry. This full-time position is based in Bonifacio Global City, Taguig City, Metro Manila, and will involve working closely with cross-functional teams to navigate the complex regulatory landscape.

What you'll be doing

1. Oversee the preparation and submission of regulatory applications, including new product registrations, variations, and renewals
2. Collaborate with R&D, quality, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle
3. Monitor and interpret changes in regulatory requirements, both locally and globally, and develop strategies to address them
4. Maintain strong relationships with regulatory authorities and industry bodies to stay abreast of the latest developments
5. Provide expert guidance and support to internal stakeholders on regulatory matters
6. Manage junior regulatory affairs professionals and oversee their training and development

What we're looking for

1. A bachelor's degree in pharmacy, pharmaceutical sciences, or a related field, with a strong understanding of regulatory affairs in the pharmaceutical industry
2. At least 4 years of experience in a similar regulatory affairs role, preferably within the pharmaceuticals or medical devices sector
3. Excellent knowledge of local and international regulatory requirements, guidelines, and best practices
4. Strong problem-solving, analytical, and critical thinking skills
5. Effective communication and stakeholder management abilities

What we offer

At Macleods Pharmaceuticals Philippines Inc, we are committed to providing a supportive and enriching work environment for our employees. In addition to a competitive salary and benefits aligned with the industry.

About us

Macleods Pharmaceuticals Philippines Inc is a wholly owned subsidiary of Macleods Pharmaceuticals Limited: India, a leading pharmaceutical company committed to improving the health and well-being of individuals across the globe. With a focus on innovation, quality, and patient-centricity, we strive to develop and deliver high-quality pharmaceutical products that make a difference in the lives of our customers. Join us on our mission to make healthcare more accessible and affordable in the Philippines.

Apply now to become our next Regulatory Affairs Manager and be a part of our growing team.

Company Description

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Role Description

This is a full-time on-site role for a Regulatory Affairs Officer located in Manila. The Regulatory Affairs Officer will be responsible for preparing and coordinating regulatory documentation, ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining up-to-date knowledge of regulatory affairs. The officer will also oversee internal audits and liaise with various departments to ensure that all operations are compliant with relevant regulations.

Qualifications

• Strong understanding of Regulatory Documentation and Regulatory Requirements
• Experience in Regulatory Compliance and Regulatory Submissions
• Proficiency in managing Regulatory Affairs
• Excellent written and verbal communication skills
• Keen attention to detail and strong organizational skills
• Ability to work independently and collaboratively within a team
• Bachelor's degree in Life Sciences, Pharmacy, or related field
• Previous experience in the pharmaceutical industry is a plus

PHILIPPINE MEDICAL SYSTEMS INC. is hiring a Full time PHARMACIST - REGULATORY AFFAIRS role in Legazpi Village, NCR. Apply now to be part of our team.

Job summary:

• Looking for candidates available to work:
• Monday: Morning, Afternoon
• Tuesday: Morning, Afternoon
• Wednesday: Morning, Afternoon
• Thursday: Morning, Afternoon
• Friday: Morning, Afternoon
• 1 year of relevant work experience required for this role
• Working rights required for this role
• Expected salary: ₱18,000 - ₱25,000 per month
• This is an immediate start position

Key Job Qualifications:

• Must possess a Bachelor/College Degree in Pharmacy
• With valid professional license
• Preferably with at least one year work related experience
• Computer literate
• Fresh Graduates are welcome to apply
• Can start immediately and with available requirements

Key Job Responsibilities:

• Acts as the company's representative in government regulatory requirements
• Processes and monitors BFAD and DOH license for renewal and accreditation and filling-out forms/payments of renewal and request of product inspection.
• Checks invoice vis-à-vis stock card of items to be delivered; simultaneously conducts daily stocks inventory.
• Must be a resident of Makati City or nearby areas.

Benefits:

• Health insurance
• Life insurance
• Retirement Plan

Schedule:

• 8 hour shift

Supplemental pay types:

• 13th month pay
• Performance bonus
• Yearly bonus

Duties & Responsibilities

• Assist in preparing all the technical documents required for submission to FDA and other regulatory agencies
• Responsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration date
• Update and monitor the registration status and validity date of all regulatory certificates and licenses
• Establish and maintain document filing system to ensure easy access
• Participate in inspections of company facilities by FDA and other applicable agencies
• Submission of Quarterly report for DOH EDPMS
• Act as a Person in charge, liaison to local regulatory bodies
• Assist in the preparation of Bidding Documents for submission on Public Bidding for Hospitals
• Assist in preparing Requirements for Hospital needs.
• Assist in Sales concerns about product specification and other concerns.
• Assist the Marketing Department with Promo Permits for FDA compliance
• Handles Batch Notification for FDA Monitoring
• Provides support and assistance to Regulatory Affairs Head
• Perform other regulatory-assigned activities and roles in support of business objectives

Qualifications

• Must be a Licensed Pharmacist
• With or Without experience working in Regulatory
• Fresh Graduaes are welcome to apply
• Background in handling government account procedures is an advantage
• Excellent leadership and management skills
• Honest, patient, and hardworking
• Willing to work onsite from Monday to Friday

Job Type: Full-time

Work Location: In person

MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision.

Applies subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Associates Degree (± 13 years)

Experience/Background

Minimum 1 year

Main Function

A Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and procedures.

Duties and Responsibilities:

Regulatory

• Initial registration and life cycle management of product licenses. ∙ Maintenance of License to Operate as Medical Device Importer/Distributor.
• Design and implementation of regulatory strategies to meet objectives and timelines set for licensing, registration of products and other related regulatory matters.
• Conduct regulatory alignment with foreign suppliers for any change in FDA regulation and updates.
• Acts as the main focal point for Philippines for any regulatory queries from suppliers and provide regulatory support as appropriate
• Attend to inspector/s during FDA audits.
• Ensure proper management and safekeeping of records in compliance with FDA regulations.
• Clearance from other non-FDA regulating bodies (OMB, NTC, etc.)
• Copy review of promotional materials.
• Monitors changes in regulatory environment and participates in relevant industry meetings in order to help shape draft regulations in the Philippines.
• Takes action accordingly to minimize any risk that the company may be subjected to.

Quality Assurance

• Prepares and updates Standard Operating Procedures (SOP), Work Instructions (WI) and policies on an as-need basis.
• Product complaints handling and reporting in accordance to supplier SOP.
• Handles Field Actions in accordance to supplier process.
• Point person during supplier audits.

Job Requirements:

• Candidate must possess at least Bachelor's/ College Degree in Pharmacy.
• Must be a registered Pharmacist.
• Newly graduate is welcome to apply.

Job Types: Full-time, Permanent

Benefits:

• Flexible schedule

Work Location: In person