Assistant Manager- Regulatory
8 hours ago
About the Role
Are you a licensed pharmacist with strong regulatory knowledge and leadership skills? We're looking for an Assistant Manager – Regulatory to join our dynamic and fast-paced team at Rudolf Lietz, Inc. (RLI)
In this role, you'll lead the Regulatory Team to ensure the company's full compliance with Philippine government regulations (FDA, BAI, PDEA, DENR, DDB, etc.), as well as client and industry standards. You will also be a key contributor to the quality, safety, and integrity of our operations.
This is more than just a compliance role — it's a critical position that connects regulatory excellence with commercial success.
Your Main Role in the Organization:
· Lead, manage, and mentor a team of Regulatory Pharmacists responsible for ensuring compliance across diverse product categories such as pharmaceuticals, animal feed, food, personal care, veterinary products, and packaging materials.
· Ensure strict adherence to regulatory requirements set by government agencies including the FDA, BAI, PDEA, DENR-EMB, DDB, and other relevant authorities.
· Oversee the preparation, submission, and timely renewal of product registrations, licenses, permits, and other regulatory documentation to maintain uninterrupted business operations.
· Coordinate and facilitate regulatory inspections, audits, and compliance assessments conducted by government bodies and third-party auditors.
· Collaborate with Sales, Product Development, and technical teams to provide expert regulatory guidance during product development, launches, and technical troubleshooting.
· Lead the preparation and submission of comprehensive regulatory compliance reports, including monthly product status updates, importation reports, and audit findings.
· Drive the company's ISO certification and compliance programs, acting as an internal audit leader and ensuring ongoing adherence to quality management system standards.
· Maintain and safeguard critical regulatory documents, manuals, technical specifications, and certification records to ensure accessibility and audit readiness.
· Serve as the primary point of contact for regulatory inquiries, complaints, and escalations within the company and from external stakeholders.
· Review and approve key regulatory documents such as QC forms, complaint reports, and other activities of Regulatory Pharmacists.
· Ensure effective communication and coordination with external agencies for licensing renewals, inspections, and regulatory submissions.
· Actively participate in cross-functional teams to support internal audits, client audits, warehouse and logistics compliance, and other corporate governance initiatives.
· Monitor emerging regulatory trends and updates, providing timely advice and training to the Regulatory team and other departments.
· Perform additional duties as assigned by the department manager or company leadership to support overall compliance and business objectives.
Qualifications
- Licensed Pharmacist with at least 5 years of experience in regulatory affairs and/or manufacturing in a private company
- In-depth knowledge of Philippine regulatory requirements (FDA, BAI, PDEA, DDB, DENR, etc.)
- Strong command of written and spoken English
- Exceptional attention to detail, especially in documentation and compliance
- Demonstrated experience in ISO compliance, including QMS or internal audit functions
- Previous experience in a leadership or supervisory role within regulatory or quality teams
- Exposure to client-side product development or technical sales support is an advantage
- Highly organized, proactive, and capable of leading a small, multi-functional team
- Able to perform well under pressure and manage multiple concurrent projects
- Proficient in Microsoft Office applications (Word, Excel, Outlook)
Perks & Benefits
- Competitive salary and performance-based incentives
30 days of Service Incentive Leave, inclusive of:
Vacation Leave (VL)
- Sick Leave (SL)
- Emergency Leave (EL)
- Mental Health Leave
- Health and Medical Insurance coverage
- Yearly performance incentives
- Retirement benefits
- Monthly communication allowance
- Free shuttle service for employees
- Opportunities for professional development and training
- Supportive, collaborative, and inclusive work culture
- Exposure to local and international regulatory practices
Join us to make a meaningful impact by ensuring safety and compliance across industries and grow your skills in a dynamic environment and enjoy the stability of a company with over 50 years of excellence
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