Regulatory Affairs Officer

Square Pharmaceutical, Inc; Carmona; On-site; PHP 420,000 - 660,000; Full time

Job summary

Square Pharmaceutical, Inc. in the Philippines seeks a Regulatory Affairs professional to prepare and submit regulatory documents, monitor changes, and liaise with agencies to ensure timely product approvals.

You will work with QA, R&D, and commercial teams to align regulatory requirements with business goals, and provide guidance on best practices. A Bachelor’s degree in Pharmacy is required.

Qualifications

• Bachelor's degree in Pharmacy or related course.
• Experience in regulatory affairs, pharmaceutical compliance, or related regulatory function.
• Strong knowledge of Philippine FDA regulations and requirements, as well as familiarity with other regulatory frameworks.
• Excellent written and verbal communication skills, with the ability to prepare clear regulatory documentation.
• Attention to detail and strong organizational skills, with the ability to manage multiple regulatory projects simultaneously.

Responsibilities

• Prepare, compile, and submit regulatory documentation and applications to pharmaceutical regulatory authorities, including product registrations, amendments, and compliance reports
• Ensure all regulatory submissions are complete, accurate, and submitted within required timelines to maintain product approvals and market access
• Monitor changes in pharmaceutical regulations, guidelines, and industry standards, and communicate these changes to relevant internal stakeholders
• Liaise with regulatory agencies to address queries, requests for additional information, and other regulatory correspondence
• Maintain and organise regulatory files in accordance with regulatory requirements and company policies, ensuring proper documentation and traceability
• Support the development and implementation of regulatory strategies for new product launches and product line extensions
• Conduct compliance audits and assessments to identify gaps and ensure adherence to regulatory requirements
• Collaborate with quality assurance, research and development, and commercial teams to align regulatory requirements with business objectives
• Provide regulatory guidance and training to cross-functional teams on regulatory requirements and best practices
• Track regulatory timelines, deadlines, and renewal dates to ensure continued product compliance and market authorisation

Skills

Regulatory affairs

Regulatory documentation

Communication

Project management

Education

Bachelor's degree in Pharmacy or related course

Job description

Key responsibilities

• Prepare, compile, and submit regulatory documentation and applications to pharmaceutical regulatory authorities, including product registrations, amendments, and compliance reports
• Ensure all regulatory submissions are complete, accurate, and submitted within required timelines to maintain product approvals and market access
• Monitor changes in pharmaceutical regulations, guidelines, and industry standards, and communicate these changes to relevant internal stakeholders
• Liaise with regulatory agencies to address queries, requests for additional information, and other regulatory correspondence
• Maintain and organise regulatory files in accordance with regulatory requirements and company policies, ensuring proper documentation and traceability
• Support the development and implementation of regulatory strategies for new product launches and product line extensions
• Conduct compliance audits and assessments to identify gaps and ensure adherence to regulatory requirements
• Collaborate with quality assurance, research and development, and commercial teams to align regulatory requirements with business objectives
• Provide regulatory guidance and training to cross-functional teams on regulatory requirements and best practices
• Track regulatory timelines, deadlines, and renewal dates to ensure continued product compliance and market authorisation

About you

• Bachelor's degree in Pharmacy or a related course
• Experience in regulatory affairs, pharmaceutical compliance, or a related regulatory function within the pharmaceutical or healthcare industry
• Strong knowledge of Philippine Food and Drug Administration (FDA) regulations and requirements, as well as familiarity with other regulatory frameworks
• Excellent written and verbal communication skills, with the ability to prepare clear and comprehensive regulatory documentation
• Attention to detail and strong organizational skills, with the ability to manage multiple regulatory projects simultaneously