195 Product Environmental Compliance Analyst jobs in the Philippines

Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services.  Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and achieve amazing results.  We are driven by our passion for success and we are proud to deliver best-in-class payment technology and software solutions.  Join our dynamic team and make your mark on the payments technology landscape of tomorrow.

PURPOSE

The purpose of the Compliance Manager role is to manage and maintain a regulatory compliance framework, promoting a compliance culture across the business.

DUTIES AND RESPONSIBILITIES

Primary

• Conduct periodic 2nd line monitoring reviews as detailed in the Compliance Monitoring Programme on a variety of 1st line activities performed by the business to ensure various regulatory requirements are being adhered to (ie. the Anti-Money Laundering policy), these will include monitoring activities like the following, but not exhaustive to:

• Newly onboarded applications by various sales channels

• Amendments to existing customer information

• Financial loss reviews as a result of a customer complaint

• Create and maintain the Monthly Information pack (reporting) as a result of the monitoring activities completed, this would include summarising how effectively the business units maintain controls and procedures to ensure regulatory standards are met and good customer outcomes are achieved

• Build relationships with key internal departments across the group; this will include when delivering feedback to departments on the results of the monitoring completed

• Assist and work closely with the Regulatory Compliance team members, provide support where required

• Coordinate and liaise with various business areas and individuals to obtain accurate information for regulatory returns with the support of Compliance team members

• Maintain current knowledge of relevant regulatory changes, and recommend improvements where required

COMPETENCIES (KNOWLEDGE / SKILLS or ABILITIES / BEHAVIOUR)

• An understanding of relevant financial regulatory laws, rules and regulations as appropriate to the card acquiring business and apply them to the business (including Anti-Money Laundering)
• Experience within a second line function or monitoring function would be advantageous
• Financial/Regulatory compliance related qualifications advantageous but not essential
• Proven excellent written and verbal communication
• Ability to objectively assess compliance standards within the business and make suitable recommendations
• Sound reasoning and decision making
• Ability to build and maintain positive working relationships
• Strong organisational skills and attention to detail
• Proven excellent IT literacy skills, including knowledge of using Google software
• Demonstrate highest standards of personal integrity and ethical behaviour
• Flexibility to work UK hours - preferably 9am - 5pm (GMT)

QUALIFICATIONS

• The ICA certificate in compliance (desirable)
• Willingness to undertake professional qualifications (desirable)

Global Payments Inc. is an equal opportunity employer.

Global Payments provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including pregnancy), national origin, ancestry, age, marital status, sexual orientation, gender identity or expression, disability, veteran status, genetic information or any other basis protected by law. Those applicants requiring reasonable accommodation to the application and/or interview process should notify a representative of the Human Resources Department.

Qualifications:

• Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent.
• Must have a valid PRC license.
• With at least 1 year of work experience in the regulatory industry, preferably in Medical Devices.
• Experience with ISO certification (i.e., ISO 9001:2015) is an advantage
• Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.

Responsibilities:

• Ensures that the company complies to all applicable regulations regarding licenses, technical documents, and product registrations such as, but not limited to: Initial application and renewal of License to Operate (LTO), Registration and Renewal of Certificate of Medical Device Notification/Registration (CMDN/CMDR) to all products carried by the company, Amendments as required by the FDA or any agency involved in the regulation of Medical Devices.
• Represent the company and serve as a liaison with regulatory authorities, including, but not limited to, the Food and Drug Authority (FDA), ensuring compliance with inspection requirements and promptly providing accurate information to queries.
• Monitors and updates records of distribution for various products distributed and sold by the company.
• Assist the inventory associates in checking the deliveries from the principals to confirm that the quantities, product numbers, and descriptions match the purchase order and packing list.
• Monitor and assist the ISO certification process, ensures that the company meet all relevant international standards and regulatory requirements
• Uphold and promote the company's ethical standards; conducting seminars and training as needed to ensure compliance across all levels of the organization.
• Liaise with and report to foreign principals for regulatory requirements and the status of product registrations.
• Contributes to team efforts by achieving related results as needed.

Company Description

Aljeron Medical Enterprises, Inc. (AMEI) is a licensed servicer, importer, and distributor of various surgical, diagnostic, laboratory, and radiological equipment and devices. With a strong network and dedicated team, AMEI has grown to become a reputable company in the industry. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, dealers, and biomedical engineers.

Job Types: Full-time, Permanent

Pay: Php30, Php35,000.00 per month

Benefits:

• Additional leave
• Company events
• Health insurance

Application Question(s):

• What's your expected basic salary?
• Where are you currently residing?
• Are you willing to work on-site?

Education:

• Bachelor's (Required)

Experience:

• Regulatory Compliance: 1 year (Required)

License/Certification:

• PRC License (Required)

Work Location: In person

Qualifications:

• Graduate of Bachelor of Science in Pharmacy, Chemistry, or equivalent.
• Must have a valid PRC license.
• With at least 1 year of work experience in the regulatory industry, preferably in Medical Devices.
• Experience with ISO certification (i.e., ISO 9001:2015) is an advantage
• Knowledge and skills in Regulatory Documentation, Compliance, and understanding of Regulatory Requirements specific to medical devices.

Responsibilities:

• Ensures that the company complies to all applicable regulations regarding licenses, technical documents, and product registrations such as, but not limited to: Initial application and renewal of License to Operate (LTO), Registration and Renewal of Certificate of Medical Device Notification/Registration (CMDN/CMDR) to all products carried by the company, Amendments as required by the FDA or any agency involved in the regulation of Medical Devices.
• Represent the company and serve as a liaison with regulatory authorities, including, but not limited to, the Food and Drug Authority (FDA), ensuring compliance with inspection requirements and promptly providing accurate information to queries.
• Monitors and updates records of distribution for various products distributed and sold by the company.
• Assist the inventory associates in checking the deliveries from the principals to confirm that the quantities, product numbers, and descriptions match the purchase order and packing list.
• Monitor and assist the ISO certification process, ensures that the company meet all relevant international standards and regulatory requirements
• Uphold and promote the company's ethical standards; conducting seminars and training as needed to ensure compliance across all levels of the organization.
• Liaise with and report to foreign principals for regulatory requirements and the status of product registrations.

Company Description

Aljeron Medical Enterprises, Inc. (AMEI) is a licensed servicer, importer, and distributor of various surgical, diagnostic, laboratory, and radiological equipment and devices. With a strong network and dedicated team, AMEI has grown to become a reputable company in the industry. Headquartered in Metro Manila, AMEI operates nationwide through its sales representatives, dealers, and biomedical engineers.

Job Types: Full-time, On-site, Permanent

Salary Range: 30, ,000

Job Objective:

The Regulatory Affairs Associate is responsible for supporting the regulatory affairs team in ensuring the company's products comply with local regulatory requirements and industry standards. This includes preparing and submitting regulatory documents, interacting with government agencies such as the Food and Drug Administration (FDA) Philippines, and ensuring that all products meet the necessary approval processes for marketing in the country.

Duties and Responsibilities:

Regulatory Submissions and Filings:

• Assist in the preparation and submission of regulatory documents, including applications for product registration, licenses, and other regulatory approvals required by the FDA Philippines and other relevant agencies.
• Prepare and review regulatory dossiers for product registrations, renewals, variations, and other regulatory filings.
• Monitor the progress of product submissions and track submission deadlines to ensure timely filings.

Regulatory Compliance and Guidance:

• Provide regulatory advice to internal teams (e.g., R&D, manufacturing, quality control) to ensure product development and manufacturing processes comply with local regulations.
• Ensure that the company's products, labeling, advertising, and promotional materials meet Philippine regulatory requirements.
• Monitor changes in regulatory laws and guidelines in the Philippines and update internal teams on new or revised requirements.

Communication with Regulatory Authorities:

• Act as a liaison between the company and local regulatory authorities, including the FDA Philippines, Department of Health (DOH), and other relevant government bodies.
• Assist in preparing responses to queries or requests from regulatory agencies and handle follow-up on submissions.
• Support the regulatory team during audits or inspections by regulatory authorities.

Post-Market Surveillance and Compliance:

• Assist in post-market surveillance activities, ensuring products remain compliant after launch in the market.
• Coordinate the preparation of periodic reports, including Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other required documentation.
• Support activities related to product recalls, if necessary, and ensure compliance with the regulatory authorities' requirements for recall procedures.

Documentation and Record Keeping:

• Maintain accurate and organized records of regulatory submissions, correspondence, and approvals.
• Assist in ensuring that regulatory documents are updated and accessible for audits, inspections, and regulatory compliance reviews.
• Keep detailed records of the company's interactions with the FDA Philippines and other regulatory bodies.

Market Intelligence and Regulatory Research:

• Stay updated on local regulatory changes, trends, and industry news to ensure the company remains compliant with evolving regulations.
• Research and analyze local regulatory requirements for new products, product changes, or market expansions.

Cross-functional Collaboration:

• Work closely with internal departments such as legal, marketing, R&D, and manufacturing to ensure that products are developed, produced, and marketed in compliance with regulatory standards.
• Assist in the preparation of regulatory strategies for new products, ensuring adherence to local regulations from the early stages of development.

Job Type: Full-time

Benefits:

• Company Christmas gift
• Company events
• Employee discount
• Opportunities for promotion
• Paid training
• Promotion to permanent employee

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Affairs Associate: 1 year (Preferred)

License/Certification:

• Licensed Pharmacist (Preferred)

Location:

• Caloocan (Preferred)

Work Location: In person

• Regulatory Submissions and Filings:
• Assist in the preparation and submission of regulatory documents, including applications for product registration, licenses, and other regulatory approvals required by the FDA Philippines and other relevant agencies.
• Prepare and review regulatory dossiers for product registrations, renewals, variations, and other regulatory filings.
• Monitor the progress of product submissions and track submission deadlines to ensure timely filings.
• Regulatory Compliance and Guidance:
• Provide regulatory advice to internal teams (e.g., R&D, manufacturing, quality control) to ensure product development and manufacturing processes comply with local regulations.
• Ensure that the company's products, labeling, advertising, and promotional materials meet Philippine regulatory requirements.
• Monitor changes in regulatory laws and guidelines in the Philippines and update internal teams on new or revised requirements.
• Communication with Regulatory Authorities:
• Act as a liaison between the company and local regulatory authorities, including the FDA Philippines, Department of Health (DOH), and other relevant government bodies.
• Assist in preparing responses to queries or requests from regulatory agencies and handle follow-up on submissions.
• Support the regulatory team during audits or inspections by regulatory authorities.
• Post-Market Surveillance and Compliance:
• Assist in post-market surveillance activities, ensuring products remain compliant after launch in the market.
• Coordinate the preparation of periodic reports, including Adverse Event Reports (AERs), Periodic Safety Update Reports (PSURs), and other required documentation.
• Support activities related to product recalls, if necessary, and ensure compliance with the regulatory authorities' requirements for recall procedures.
• Documentation and Record Keeping:
• Maintain accurate and organized records of regulatory submissions, correspondence, and approvals.
• Assist in ensuring that regulatory documents are updated and accessible for audits, inspections, and regulatory compliance reviews.
• Keep detailed records of the company's interactions with the FDA Philippines and other regulatory bodies.
• Market Intelligence and Regulatory Research:
• Stay updated on local regulatory changes, trends, and industry news to ensure the company remains compliant with evolving regulations.
• Research and analyze local regulatory requirements for new products, product changes, or market expansions.
• Cross-functional Collaboration:
• Work closely with internal departments such as legal, marketing, R&D, and manufacturing to ensure that products are developed, produced, and marketed in compliance with regulatory standards.
• Assist in the preparation of regulatory strategies for new products, ensuring adherence to local regulations from the early stages of development.

Job Type: Full-time

Benefits:

• Company Christmas gift
• Company events
• Employee discount
• Opportunities for promotion
• Paid training
• Promotion to permanent employee

Education:

• Bachelor's (Preferred)

Experience:

• Regulatory Pharmacist: 1 year (Preferred)

Language:

• English (Preferred)

Work Location: In person

• Regulatory Compliance: Represent the company in complying with government regulating bodies' requirements for products and facilities (excluding local permits).
• Documentation & Registration: Check necessary documents and create Product Information Files (PIF) for FDA product registration.
• Product Development Understanding: Understand all aspects of product development, including research, clinical trials/tests, manufacturing practices, regulations, and approval processes.
• Project Team Participation: Participate with project teams on regulatory requirements for export, labeling, or clinical study compliance.
• Guidance & Interpretation: Provide and explain regulations, policies, or procedures, and identify/interpret regulatory guidelines.
• Law Evaluation: Evaluate applicable laws and regulations to determine their impact on company activities.
• Documentation Coordination: Coordinate regulatory documentation activities.

• Education: Licensed Pharmacist or Chemical Engineer.
• Experience: Relevant years of related work experience.
• Skills: Proficient in oral and written communication; Computer literate.

Location: BGC, Taguig

Schedule: Night shift

Work set-up: Hybrid

Position Overview:

A Regulatory Compliance Specialist begins their day by reviewing their workload to prioritize those items which need to be addressed that day. Workload is assigned two months in advance allowing for ample time to plan workload tasks and related activities. Phone interaction with regulatory agencies and customers should be expected each day as applicable to the disclosure being completed. Multi-tasking each day will be required to include tasks as varied disclosure workload, internal process improvements, client/agency interaction via phone or email.

Job Responsibilities:

• Timely, accurate completion of applicable customer deliverables
• Self-monitoring of regulatory workload tasks on a daily basis+A20:B28
• Monitoring and maintenance of Compliance CalendarTM, as applicable, and ensuring all workload tasks are completed pursuant to job responsibilities
• Participate as requested in development and implementation of regulatory quality and process improvement initiatives, as applicable
• Tracking and maintenance of applicable customer data into various software platforms and hard copy forms
• Provide support and guidance to customers within parameters of defined processes and procedures
• Interact with local, state and federal agencies regarding disclosure requirements and applicable regulations as needed (Please note no previous experience is required for this responsibility)
• Regulatory Location Document maintenance in Regulatory Module
• Completes any special projects or other duties, as applicable
• Must be able to perform duties with or without reasonable accommodation.

Qualifications:

• Bachelors degree
• Two or more years experience in EHS related field preferred
• Cursory knowledge of 40CFR and International Fire Code regulations preferred
• Basic computer proficiency and experience with Microsoft Office suite
• Highly motivated, organized, and excellent written and verbal communication skills
• Excellent customer service and interpersonal skills
• Must be detail oriented and able to multi-task to meet standard response times and daily deadlines
• Ability to work independently and collaboratively
• Forward thinking and ability to accommodate development of skill sets to accommodate business needs
• Experience balancing job role expectations against strict deadlines
• Ability to review, interpret and summarize Federal, State and International compliance regulations

Desirable Skills:

• 2+ years of experience in an EHS related field preferred

Company Overview

TOPLC Biomedical, Inc. is a company that specializes in manufacturing and importation of food supplements, cosmetics and medical devices under our clients' house brands. With factories located in Taiwan, TOPLC is proud to provide high-quality, safe and unique products to the market.

Benefits:

Bonuses:

1.    Signing bonus worth Php 50,000 to 100,000

2.    Annual Bonus worth 1-2 months salary

3.    Service Bonus

4.    Attendance Bonus

5.    Incentive Leaves and Long Holidays

6.    Health Maintenance Organization (HMO-Employee with dependents included)

7.    Opportunity to travel to Taiwan

Your responsibilities will include:

· Prepares & submits documents to Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) & drug product - ACTD document for Initial registration, Site Registration/GMP Clearance applications, BA/BE study report, renewal of CPR, including variations and compliance of existing products.

· Must know or have an experience applying Initial and renewal application for drug products.

· Monitors the status of applications with the FDA.

· Creates and reviews packaging layouts in line with existing standards set by FDA.

· Handles company inspection and audit relevant to third party and government agencies.

· Handles applications with Intellectual Property Office (IPO) for trademarks and other functions of the agency.

· Directly reports to Regulatory Manager.

To be successful in this role, you will need to have:

· Bachelor's Degree in Pharmacy or any related courses in Medical Field.

· At least 2 years of working experience as Regulatory Compliance Officer.

· Detail oriented and attention to accuracy.

· Excellent communication and interpersonal skills.

Why join us?

· Multinational Company based in Taiwan and Philippines.

· Trending Healthcare Industry.

· Top Class Training.