Regulatory Manager - Global Pharma

A leading multinational organisation is seeking a Regulatory Manager to join their team in BGC. This is an exceptional opportunity for you to play a pivotal role in ensuring regulatory compliance across the full product lifecycle, from research and development through to post-market surveillance.

The company is renowned for its commitment to quality, ethical standards, and continuous professional growth, offering a supportive environment where your expertise will directly contribute to the success of innovative healthcare solutions. You will be empowered to shape robust compliance frameworks, collaborate with diverse teams, and maintain transparent relationships with Philippine health authorities. If you are passionate about regulatory affairs and eager to make a meaningful impact within a highly respected industry leader, this position offers the perfect platform for your career advancement.

What Youll Do

As Regulatory Manager based in BGC, you will immerse yourself in a multifaceted role that places you at the heart of regulatory operations. Your day-to-day responsibilities will involve close collaboration with both internal teams and external agencies to ensure that every aspect of product development and distribution meets stringent local requirements. You will champion best practices in compliance by designing robust programmes that safeguard against risk while supporting business growth. By providing expert advice across departments, whether it’s guiding R&D on dossier preparation or coaching marketing on advertising standards, you will help embed a culture of accountability throughout the organisation. Your ability to interpret complex regulations will be crucial as you navigate changes in legislation and respond swiftly to emerging challenges. Success in this role means not only keeping the company audit-ready but also empowering colleagues through training initiatives that elevate collective understanding of compliance imperatives.

• Act as the primary liaison with Philippine regulatory bodies, including the Food and Drug Administration (FDA), Department of Health (DOH), Bureau of Customs (BOC), Department of Trade and Industry (DTI), and other relevant authorities to ensure all company operations comply with local laws and regulations.
• Conduct comprehensive internal audits and compliance risk assessments to proactively identify process gaps, ensure audit readiness, and maintain high standards of regulatory compliance.
• Develop, implement, and continuously enhance compliance programmes, policies, standard operating procedures (SOPs), and control systems that meet or exceed Philippine regulatory requirements.
• Oversee regulatory compliance across the entire product lifecycle, from research and development to manufacturing, labelling, advertising, distribution, post-market surveillance, adverse event reporting, and product recalls.
• Manage regulatory inquiries for all products per SKU, ensuring timely responses and overseeing the renewal and maintenance of corporate Licenses to Operate (LTOs) to prevent lapses in regulatory standing.
• Monitor and assess changes in relevant laws, regulations, and standards, including those from the FDA, GMP, GDP, and related agencies, to determine their operational impact and ensure timely compliance actions.
• Supervise the preparation, review, and submission of regulatory documentation for new product registrations, renewals, and variations, ensuring all filings are accurate, complete, and submitted on time.
• Provide expert regulatory advice and conduct compliance training sessions for cross-functional teams such as R&D, QA Manufacturing, and Marketing to promote a strong culture of compliance.
• Identify potential compliance risks early and develop corrective and preventive action plans (CAPAs) to mitigate future issues and strengthen internal compliance frameworks.
• Support strategic business objectives by ensuring timely product approvals, maintaining open communication with regulators, and facilitating smooth market entry and operations within the Philippines.
  
  

What You Bring

To excel as Regulatory Manager you will bring an impressive blend of technical proficiency industry insight interpersonal finesse organisational acumen. Your background should reflect substantial hands-on experience navigating complex regulatory environments particularly within pharmaceuticals sectors. A deep familiarity with Philippine FDA regulations coupled with practical know-how preparing submitting detailed dossiers ensures you can handle even the most intricate approval processes efficiently. Your leadership qualities shine through your history guiding teams through audits implementing corrective actions driving continuous improvement initiatives. Communication comes naturally whether articulating nuanced legal updates to stakeholders or building rapport with government officials. Adaptability meticulous attention detail allow you juggle competing priorities without compromising quality while your commitment upholding ethical standards inspires trust among colleagues partners alike. Ultimately your holistic approach enables you not only meet but exceed expectations safeguarding both public health organisational reputation.

• A Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or Business Administration is required; holding a Professional License (e.g., Registered Pharmacist) or advanced certifications such as RAC (Regulatory Affairs Certification), QPIRA (Qualified Person in Regulatory Affairs), or CCEP (Certified Compliance & Ethics Professional) is highly advantageous.
• At least 7–10 years of progressive experience in regulatory affairs or compliance within the pharmaceutical industry is essential.
• Demonstrated expertise in managing regulatory submissions and maintaining direct interactions with Philippine regulatory bodies such as the FDA, DOH, DTI, BOC, DENR, or PEZA is required.
• Comprehensive knowledge of Philippine FDA laws, including RA 9711 (Food and Drug Administration Act of 2009), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) guidelines, and other local or ASEAN regulatory frameworks is necessary.
• Proven ability to prepare, review, and oversee product registration dossiers, License to Operate (LTO) applications, Certificates of Product Registration (CPR), renewals, and amendment filings, with experience using electronic submission platforms preferred.
• Experience leading or supporting regulatory audits, post-market surveillance, product recalls, and Corrective and Preventive Action (CAPA) implementation, coupled with a strong grasp of compliance documentation and reporting standards, is important.
• Excellent written and verbal communication skills in English and Filipino, enabling effective liaison with regulators and clear communication of updates across internal stakeholders, are expected.
• Proven track record in leading compliance or regulatory teams and collaborating cross-functionally fostering a culture of accountability and excellence, is highly valued.
• Strong analytical and problem-solving skills with the demonstrated ability to interpret complex regulatory issues, assess emerging laws, and implement appropriate risk mitigation strategies.
• Highly organised, detail-oriented, and proactive, with a strong sense of integrity, accountability, and adaptability, and the ability to manage multiple projects simultaneously in a dynamic regulatory environment.
  
  

What Sets This Company Apart

This organisation stands out for its unwavering dedication to quality patient safety ethical conduct across all operations. With a global presence yet strong local roots it fosters an inclusive environment where every team member’s contribution matters. Employees benefit from flexible working arrangements generous support for ongoing training opportunities access knowledgeable mentors who encourage personal professional growth. The company’s collaborative ethos ensures everyone feels connected supported regardless department function creating sense belonging shared purpose. By joining this team you become part network committed making positive difference lives countless individuals while advancing your own career within respected industry leader known integrity innovation resilience.

Whats Next

If you are ready to take your expertise in regulatory affairs to new heights within an organisation that values your contribution apply now for this rewarding opportunity!

Apply today by clicking on the link provided – don’t miss your chance to make an impact!



Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.

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