112 Regulatory Affairs Manager jobs in the Philippines

Job Summary:

The Regulatory Affairs Manager is responsible for ensuring that the company's products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines. The Regulatory Affairs Manager will also collaborate with cross-functional teams to provide guidance on regulatory issues and strategies.

Key Responsibilities:

1. Regulatory Compliance and Strategy:

2. Lead and manage regulatory submissions and ensure compliance with local regulations.

3. Develop regulatory strategies for the approval and commercialization of products or product changes.
4. Keep abreast of changing regulations and ensure the company remains in compliance with evolving regulatory environments.

5. Product Registration and Documentation:

6. Prepare, review, and submit regulatory documents, including product dossiers, to relevant regulatory agencies.

7. Coordinate with internal teams to ensure that all necessary documentation for regulatory submissions is accurate and complete.
8. Maintain regulatory files and ensure they are up to date and readily accessible.

9. Cross-functional Collaboration:

10. Work closely with marketing teams to provide regulatory input and ensure compliance is integrated into the planning.

11. Provide regulatory guidance and support to cross-functional teams, ensuring the timely and successful approval of products or product changes.
12. Assist in the preparation of marketing materials and labeling to ensure compliance with regulatory requirements.

13. Regulatory Approval Process:

14. Manage the regulatory approval process for products, product changes, and renewals, ensuring timely approvals in target markets.

15. Communicate with regulatory agencies as needed to clarify issues, respond to inquiries, or resolve regulatory concerns.

16. Risk Assessment and Compliance Monitoring:

17. Identify regulatory risks related to marketing, or distribution, and recommend mitigation strategies.

18. Monitor product performance post-market to ensure continued compliance with regulatory requirements.
19. Review and assess the impact of new or revised regulations on current and future products.

20. Regulatory Affairs Training:

21. Educate and train internal teams on regulatory affairs and compliance requirements.

22. Conduct workshops or presentations to ensure team members are aware of regulatory standards and best practices.

23. Regulatory Reporting and Documentation:

24. Maintain and track regulatory submissions and approvals, preparing status reports for senior management.

25. Prepare regulatory updates and reports for regulatory authorities, as needed.

26. Audit and Inspection Support:

27. Support internal and external audits related to regulatory compliance.

28. Participate in regulatory inspections or audits and manage the documentation and communication during such events.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or a related field.
• Experience: 5+ years of experience in regulatory affairs, preferably in the relevant industry (e.g., pharmaceuticals, medical devices, direct-to-consumer).
• Knowledge: In-depth knowledge of local regulatory requirements and regulatory submission processes.

• Skills:

• Strong communication, organizational, and project management skills.

• Ability to interpret and apply regulatory guidelines and laws.
• Excellent attention to detail and ability to manage multiple priorities.
• Experience with regulatory submission software and tools.
• Ability to work cross-functionally with different departments and stakeholders.

• Oversee the preparation and submission of regulatory documentation, including marketing authorisation applications, variations, renewals, and other regulatory filings
• Collaborate with internal stakeholders, such as R&D, quality, and manufacturing, to ensure regulatory compliance throughout the product lifecycle
• Monitor and interpret changes in relevant regulations, guidelines, and industry best practices, and advise the organisation accordingly
• Represent the company in meetings with regulatory authorities and participate in inspections and audits
• Provide regulatory guidance and support to cross-functional teams to facilitate timely and successful product launches
• Contribute to the development and implementation of the company's regulatory strategy and roadmap
• Stay up-to-date with the latest trends and developments in the pharmaceutical and medical device regulatory landscape

What we're looking for

• Bachelor's degree in Pharmacy, Life Sciences, or a related experience with pharmacy license.
• Minimum 3 years of experience in a regulatory affairs role within the pharmaceutical or medical device industry
• Thorough understanding of drug and medical device regulations, particularly in the Philippines and other key markets
• Excellent written and verbal communication skills, with the ability to effectively liaise with cross-functional teams and regulatory authorities
• Strong project management and problem-solving skills, with the ability to work independently and prioritise multiple tasks
• Proactive and detail-oriented approach, with a commitment to maintaining and improving regulatory compliance
• Experience in preparing and submitting marketing authorisation applications and variations is highly desirable

About us

MSN LABS PHILIPPINES INC.' is a leading pharmaceutical and medical device company dedicated to the development, manufacture, and distribution of high-quality healthcare products. With a strong presence in the Philippines and a global reach, we are committed to improving the lives of patients through innovative and sustainable solutions. Our mission is to be the trusted partner of healthcare professionals and patients alike, and we strive to uphold the highest standards of quality, safety, and ethical conduct in all that we do.

If you're excited by the prospect of joining a dynamic and forward-thinking team in the healthcare industry, we encourage you to apply for this Regulatory Affairs Manager role at MSN LABS PHILIPPINES INC.' today.

• Bachelor's degree in a relevant scientific field (biology, chemistry, pharmacy, etc.)
• Master's degree or professional certification in Regulatory Affairs (preferred)
• Deep knowledge of regulatory requirements within the specific industry (pharmaceuticals, medical devices, food, cosmetics)
• Understanding of global regulatory landscapes and their implications
• Proficiency in regulatory submission processes and documentation
• Excellent communication skills (both written and verbal) to interact with regulatory agencies and internal stakeholders
• Strong analytical and problem-solving abilities
• Attention to detail to ensure accuracy in regulatory submissions
• Project management skills to manage complex regulatory timelines and processes
• Proven track record of successful regulatory submissions
• Experience interacting with regulatory agencies

• Bachelor's degree in a relevant scientific field (biology, chemistry, pharmacy, etc.)
• Master's degree or professional certification in Regulatory Affairs (preferred)
• Deep knowledge of regulatory requirements within the specific industry (pharmaceuticals, medical devices, food, cosmetics)
• Understanding of global regulatory landscapes and their implications
• Proficiency in regulatory submission processes and documentation
• Excellent communication skills (both written and verbal) to interact with regulatory agencies and internal stakeholders
• Strong analytical and problem-solving abilities
• Attention to detail to ensure accuracy in regulatory submissions
• Project management skills to manage complex regulatory timelines and processes
• Proven track record of successful regulatory submissions
• Experience interacting with regulatory agencies

We are looking for an experienced and detail-oriented Regulatory Affairs (RA) and Quality Assurance (QA) Manager to lead the implementation of company-wide quality systems and ensure full compliance with regulatory requirements.

This critical role involves managing audits, maintaining product quality, overseeing documentation, and serving as the primary liaison with regulatory agencies.

This position is ideal for professionals with a strong background in highly regulated industries such as pharmaceuticals, cosmetics, food, or medical devices.

Key Responsibilities

• Develop, implement, and maintain company quality procedures, SOPs, and documentation systems.
• Ensure full compliance with local and international regulations, including FDA, ISO, GMP, and other applicable standards.
• Plan and conduct internal and external audits; manage third-party inspections and regulatory reviews.
• Lead the investigation, documentation, and resolution of non-conformances; oversee corrective and preventive action (CAPA) processes.
• Investigate and resolve customer complaints, ensuring appropriate documentation and follow-up.
• Qualify and monitor suppliers to ensure ongoing compliance with company quality standards.
• Lead and mentor the QA/RA team; conduct training programs to promote compliance and quality awareness across departments.
• Manage product registration, labeling compliance, and coordinate all required regulatory submissions.
• Track and analyze quality metrics; generate regular compliance and performance reports for senior management.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 5 years in QA/RA roles, with increasing responsibilities in a regulated industry such as pharmaceuticals, medical devices, food, or cosmetics.
• Deep understanding of FDA regulations, ISO standards, GMP practices, and end-to-end product lifecycle requirements.
• Strong leadership and critical thinking abilities
• Excellent documentation and organizational skills
• Clear and effective communication across teams and regulatory bodies

Job Type: Full-time

Pay: Php60, Php80,000.00 per month

Work Location: In person

Graduate of any four (4) year course.

• Bachelor's degree in Life Sciences or a related field; advanced degree preferred.

• Extensive experience in regulatory affairs, including drug development, manufacturing, and commercialization.

• Proven leadership and project management capabilities.

• Experience working across multiple regulatory functions and strong partnerships with FDA.

• Knowledgeable with Permits and Licenses, Liaison, Effective Internal and External Communication, Strong Leadership, Emotional Intelligence, Delegation, Organizational and Management Skills.

• Goal Oriented, highly motivated, organized and with keen eye for detail

• Have succeeded leadership roles over the last 10-12 years with 3 years in the same capacity or level

• Work with leadership to deliver quality output, monitor and communicate status and progress towards the goals.

• Excellent and professional communicator across written, verbal and presentations

• Communicates, builds and maintains good working relationship between the team, different departments, stakeholders, top level executives and various government offices

• Delegates tasks effectively.

• Sets schedule, timeline and target among team members and concerned departments to deliver quality output/ results within the agreed time frame.

• Provides support, motivation, assistance and mentoring among team members to improve process, to avoid possible setbacks and to deliver quality results/output.

• Plans and identifies seminars, trainings, workshops, etc. that will be of help to the team members in order improve their skills, knowledge, etc. That may also help them and the team to meet the goal and deliverables.

Salary Budget: 90k to 120k

Type of employment: Regular/Contractual: Regular

Work location: Pasig

Work arrangement: Hybrid

Join the World's Most International Company

Are you ready to embark on an exciting journey with a company that has been at the forefront of cross-border express delivery since 1969? At DHL Express, we operate in over 220 countries and territories, making us the most international company in the world. Our mission is to connect people and improve lives across the globe, and we believe that the more people we connect, the better our planet becomes.

Join the DHL Express Family: Where Diversity Thrives

At DHL Express, we don't just talk the talk—we walk the walk As an equal opportunity employer, we are on a mission to create a vibrant, diverse, and inclusive culture that reflects the world we serve. We believe that every individual brings unique talents and perspectives to the table, and that's what makes our team truly extraordinary.

No Labels, Just Talent We celebrate differences, whether it's race, color, gender, sexual orientation, age, ability, marital status, family responsibilities, religion, political beliefs, or national origin. We're all about breaking down barriers and building bridges—because diversity fuels innovation and drives success

Overall Role Purpose:

Identify, develop and prioritize initiatives that will improve the quality of service to DHL customers, inbound / outbound transit time and the overall cost position. Develop relationships with National Customs and other regulatory authorities.

Customer External:

Customers

• Contact at top management level to communicate DHL progress, activities, and plans.
• Understand customer needs and devise specific solutions if required.
• Promote company's interest to expand customer base.
• Advise on how to facilitate customs clearance and how to reduce logistics cost.

Internal:

Country Manager

• Advise on how to facilitate customs clearance and how to reduce logistics costs.
• Support strategic initiatives with regulatory authorities.
• Represent DHL in Business/Industry/Media Forums

National Gateway Director

• Interpret and implement regulatory guidelines.
• Set strategies, plans, and process for custom in specific country.

Other functions

• Provide technical support to the National Commercial and GMNC Groups

Other functions (National Commercial and GMNC group)

Provide technical support to the National Commercial and GMNC Group.

Stakeholder External:

Industry Associations, Airport authorities, Brokerage

• Coordinate and support for the overall benefit of the industry

Customs broker:

• Keep closely monitor against SLA to improve the performance related DHL KPI and reduce clearance cost.
• Maintain good relationship.

Regulatory authorities

Represent DHL interests at all levels of Customs & Regulatory administration with professionalism and integrity.

Act as the company representative in discussions & negotiations with customs authorities & other border agencies.

Present initiatives to and actively lobby Government and other regulatory authorities to facilitate the customs clearance process.

Stakeholder Internal:

Regional Customs Management

• Work closely with the Regional Customs and Regulatory Affairs Managers in the develop of regional/country strategies and tactic.

Operations Management, Hub / Gateway departments

• Work closely with the Operations Management team to identify, develop, and priorities initiatives that will improve the quality of service to DHL customers, inbound / outbound transit time and the overall cost position.
• Work with the Sales groups to advise customers only customs/trade regulations and with country operations management to streamline clearance activity and lower cost.

Process:

Customs and Regulatory Affairs Management

• Implement a sound customs strategy with programs and projects developed in line with the key aspirations of improved clearance performance and reduced cost.
• Identify opportunities, both internal and external and recommend initiatives that will facilitate the customs clearance process.
• Conduct regular audits of clearance performance to ensure compliance to network standards and achievement of the best-cost position.
• Identify opportunities and impediments in the areas of international trade facilitation, export incentive schemes, trade and policy development and bilateral and multilateral country agreements and work with country management to implement solutions.
• Ensure DHL customs processes are in compliance with all local laws, regulations & practices.

Training about Customs and Regulatory Affairs

• Identify and assist in the implementation of training programs.

Project Management

• Plan, implement and execute identified projects.
• Provide technical support to specified projects.

What we Need?

• Experience gained through country import/export industry at a senior level
• 5 years relevant experience
• 2 years' experience at a managerial level
• Established network of contacts within the customs and regulatory environment
• Degree in related discipline or equivalent
• Presentation skills (excellent)

COMPETENCES:

Competency segment Business

• Customer Orientation: Is focused on identifying and understanding each customer's needs. Expresses and acts on desire to assist customers in an efficient and friendly manner.
• Business Acumen: Understands business principles and language, including the fundamentals of finance and profitability. Uses this understanding to achieve results and to increase the performance and profitability of our company.
• Cross Border Thinking: Has a holistic mindset and stays abreast of important trends that may affect our competitiveness as a group. Manages the business, giving priority to the international position of our company.

Competency segment 'Leadership'

• Shaping Direction: Develops and communicates strategies and goals that achieve competitive advantage. Demonstrates a clear understanding of the organization's strengths, weaknesses, opportunities and threats.
• Constructive Challenge: Contributes to an environment where people at all levels stand up for their ideas and where the status quo can always be challenged for the better.
• Building and Leading Teams: Knows the talent* needs of the team. Attracts and develops the people who can meet those needs. Encourages effective cooperation among team members and between teams. Inspires team spirit and the commitment to achieve high standards of performance

Competency segment 'Personal'

• Building and Managing Partnerships: interpersonal styles to create and sustain effective relationships with business partners (e.g. suppliers, joint venture partners, industry groups, competitors, governments, unions) and colleagues. Is open to approaches that meet mutual goals.
• Commitment to Excel: Challenges self and others to exceed standards and achieve extraordinary results striving for best-in-class. Is not easily deterred when obstacles or delays are encountered.

What You'll Do:

-Oversee customs compliance and regulatory affairs to ensure our operations meet all legal requirements.

-Collaborate with cross-functional teams to streamline processes and enhance efficiency.

-Stay ahead of industry trends and changes in regulations to keep our operations compliant and competitive.

-Develop and implement training programs to educate staff on customs regulations and best practices.

What We're Looking For:

-Proven experience in customs and regulatory affairs, with a strong understanding of international trade regulations.

-Excellent communication and negotiation skills to liaise with government agencies and stakeholders.

-Strong analytical skills and attention to detail to ensure compliance and mitigate risks.

-A proactive approach to problem-solving and the ability to thrive in a fast-paced environment.

Key Duties and Responsibilities:

• Regulatory Submissions: Prepare, review, and submit product registration

applications for medical devices, diagnostic reagents, and medical equipment to the Philippine FDA.

• Compliance Monitoring: Ensure that all products comply with the regulatory

requirements of the Philippine FDA, including standards for safety, efficacy, and labeling of medical devices and machines.

• Product Documentation: Maintain and update technical documentation, product

dossiers, and ensure timely submission of regulatory documents and reports.

• Liaison with FDA and Authorities: Serve as the primary point of contact with

the Philippine FDA and other regulatory bodies to facilitate product approvals, renewals, and post-market surveillance activities.

• Regulatory Strategy: Develop and implement regulatory strategies to optimize

registration timelines and ensure smooth market access for new and existing products.

• Cross-functional Collaboration: Work closely with the R&D, Quality Assurance,

and Marketing teams to ensure all products meet regulatory requirements throughout their lifecycle.

• Training and Updates: Stay informed on changes in local and international

regulations and provide regulatory training and updates to internal teams. Skills and Qualifications:

• Licensed Pharmacist in the Philippines.
• Minimum of 5 to 10 years of experience in regulatory affairs, specifically

with medical devices, reagents, or machines or in similar industry.

• In-depth knowledge of Philippine FDA regulations related to medical devices,

diagnostic reagents, and medical equipment.

• Strong understanding of product registration processes and post-market

compliance.

• Excellent communication and interpersonal skills to liaise with regulatory

bodies and internal teams.

• Detail-oriented, with strong organizational and project management abilities.

Job Type: Full-time

Pay: Php40, Php50,000.00 per month

Benefits:

• Opportunities for promotion
• Paid toll fees
• Paid training
• Promotion to permanent employee

Ability to commute/relocate:

• San Juan (National Capital Region): Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs Manager: 5 years (Required)

License/Certification:

• Pharmacist (Required)

Willingness to travel:

• 75% (Preferred)

Work Location: In person