Senior Regulatory Officer

1 week ago

Makati City, National Capital Region, Philippines L. MEYERF PHARMA, INC. Full time ₱1,500,000 - ₱2,500,000 per year

Position Summary

The Senior Regulatory Officer is responsible for ensuring compliance with all applicable pharmaceutical regulatory requirements and guidelines. The role involves managing the preparation, submission, and maintenance of product registrations, licenses, and regulatory documents. The Senior Regulatory Officer also provides guidance to junior team members and collaborates with cross-functional departments to support product development, commercialization, and post-marketing activities.

Key Responsibilities

  • Regulatory Submissions & Compliance
  • Prepare, review, and submit regulatory dossiers for new product registrations, renewals, and variations.
  • Ensure timely approval of product applications in compliance with FDA and other regulatory agencies.
  • Monitor changes in regulatory requirements and provide updates to management and relevant departments.
  • Maintain regulatory files, product licenses, and certificates.
  • Cross-functional Support
  • Coordinate with R&D, Quality Assurance, Production, and Marketing to ensure regulatory requirements are integrated into product development and manufacturing.
  • Review promotional and packaging materials for compliance with regulatory standards.
  • Audits & Inspections
  • Assist in preparation and participation during regulatory authority inspections and audits.
  • Ensure compliance with Good Manufacturing Practice (GMP) and other applicable guidelines.
  • Team Leadership & Guidance
  • Provide mentorship and guidance to Regulatory Officers and Assistants.
  • Review work outputs of junior staff to ensure accuracy and regulatory compliance.
  • Continuous Improvement
  • Keep updated with current regulations, trends, and industry best practices.
  • Recommend process improvements for efficient regulatory operations.

Qualifications

  • Bachelor's Degree in Pharmacy, Chemistry, Biology, or related field.
  • Licensed Pharmacist (preferred/required depending on company policy).
  • Minimum of 3–5 years' experience in regulatory affairs within the pharmaceutical industry.
  • Strong knowledge of FDA regulations, ICH guidelines, GMP, and other relevant local/international requirements.
  • Excellent technical writing, documentation, and communication skills.
  • Detail-oriented, organized, and able to manage multiple priorities.
  • Proficiency in MS Office applications and regulatory databases.

Key Competencies

  • Regulatory knowledge and compliance focus
  • Analytical and problem-solving skills
  • Strong leadership and mentoring ability
  • Effective communication and stakeholder management
  • Project management and time management

Working Conditions

  • Office-based with occasional visits to regulatory agencies.
  • May require extended working hours during regulatory submission deadlines or inspections.
  • Amenable to report in Makati City

Job Type: Full-time

Work Location: In person

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