Regulatory Pharmacist

Delta Kappa Commerce Corporation; Makati; On-site; PHP 900,000 - 1,200,000; Full time

Job summary

Delta Kappa Commerce Corporation in Makati City, Metro Manila is seeking a Regulatory Pharmacist for full-time regulatory affairs. You will liaise with regulatory bodies, ensure GMP/GDP compliance, and oversee registration, licensing, labeling, and documentation to uphold safety, efficacy, and compliance across pharmaceutical operations.

Ideal candidates hold a Philippine pharmacy license with PRC registration and a minimum of 3 years in regulatory affairs, with strong English and Filipino

Qualifications

• Bachelor's degree in Pharmacy from an accredited institution.
• Valid Philippine pharmacy licence and PRC registration.
• Minimum of 3 years' post-qualification experience in regulatory affairs.
• In-depth knowledge of Philippine pharmaceutical regulations and BFD requirements.
• Strong understanding of GMP and GDP principles.
• Experience preparing and submitting regulatory documentation and applications.
• Excellent written and verbal communication in English and Filipino.
• Strong attention to detail and ability to manage multiple regulatory projects.
• Proficiency in MS Office and relevant software.
• Ability to work independently and collaboratively with cross-functional teams.
• Knowledge of pharmacovigilance and adverse event reporting is advantageous.
• ISO certifications experience preferred.

Responsibilities

• Ensuring all pharmaceutical operations comply with national and international regulatory requirements.
• Reviewing, preparing, and submitting regulatory documentation and applications to relevant authorities.
• Developing and implementing SOPs to maintain regulatory compliance.
• Monitoring regulatory changes and advising on policy adjustments.
• Conducting internal audits and inspections for compliance.
• Liaising with regulatory agencies and responding to inquiries.
• Providing training to staff on regulatory compliance.
• Managing product registration, licensing, and labelling requirements.
• Reviewing product information, inserts, and promotional materials for compliance.
• Maintaining comprehensive regulatory records.

Skills

Regulatory affairs

GMP knowledge

GDP knowledge

Regulatory submissions

Communication skills

Attention to detail

Cross-functional work

MS Office

Education

Bachelor's degree in Pharmacy

Job description

About the role

Delta Kappa Commerce Corporation is seeking a Regulatory Pharmacist to join our pharmacy operations in Makati City, Metro Manila. This is a full-time position that plays a crucial role in ensuring our pharmaceutical operations comply with all regulatory requirements and industry standards. As Regulatory Pharmacist, you will be the key liaison between our organisation and regulatory bodies, ensuring that all pharmaceutical products and practices meet the highest standards of safety, efficacy, and compliance. This position is essential to maintaining our commitment to quality and protecting public health whilst supporting our business objectives.

Key responsibilities

• Ensuring all pharmaceutical operations comply with national and international regulatory requirements and guidelines

• Reviewing, preparing, and submitting regulatory documentation and applications to relevant authorities

• Developing and implementing standard operating procedures to maintain compliance with pharmaceutical regulations

• Monitoring changes in regulatory requirements and advising the organisation on necessary adjustments to policies and practices

• Conducting internal audits and inspections to verify compliance with regulatory standards

• Liaising with regulatory agencies and responding to inquiries or inspection requests

• Providing training and guidance to pharmacy staff on regulatory compliance and best practices

• Managing product registration, licensing, and labelling requirements

• Reviewing pharmaceutical product information, package inserts, and promotional materials for regulatory compliance

• Maintaining comprehensive documentation and records related to regulatory matters

What we're looking for

• Bachelor's degree in Pharmacy or equivalent qualification from an accredited institution

• Valid Philippine pharmacy licence and professional registration with the Professional Regulation Commission (PRC)

• Minimum of 3 years' post-qualification experience in pharmaceutical regulatory affairs or compliance

• In-depth knowledge of Philippine pharmaceutical regulations, Bureau of Food and Drugs (BFD) requirements, and international regulatory standards

• Strong understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) principles

• Demonstrated experience in preparing and submitting regulatory documentation and applications

• Excellent written and verbal communication skills in English and Filipino

• Strong attention to detail and ability to manage multiple regulatory projects simultaneously

• Proficiency in relevant software systems and MS Office applications

• Ability to work independently and collaboratively with cross-functional teams

• Knowledge of pharmacovigilance and adverse event reporting procedures is advantageous

• Experience with quality management systems and ISO certifications is preferred