Regulatory Affairs Specialist

8trive; Valenzuela; On-site; PHP 420,000 - 660,000; Full time

Job summary

8trive in the Philippines is seeking a Regulatory Affairs professional to support regulatory documentation, submissions, and filing of accurate regulatory records.

Ideal candidates will have solid knowledge of regulatory compliance and requirements, and expertise in coordinating regulatory activities with regulators and internal teams.

Experience in regulated industries and familiarity with local Philippine regulations, as well as international frameworks (FDA, EMA, ISO), is a plus.

Qualifications

• Strong skills in Regulatory Documentation and Regulatory Submissions to prepare and file records.
• Solid knowledge of Regulatory Compliance and Regulatory Requirements to meet standards.
• Expertise in Regulatory Affairs to coordinate activities with regulators and internal teams.
• Experience in compliance, quality assurance, or legal support in regulated industries is beneficial.
• Bachelor’s degree in related field or equivalent practical experience.
• Strong analytical, documentation, and organizational skills with attention to deadlines.
• Excellent verbal and written communication; able to work on-site with diverse teams.
• Familiarity with local Philippine regulations and international frameworks (FDA, EMA, ISO) is a plus.

Skills

Regulatory Docs

Regulatory Submissions

Regulatory Compliance

Regulatory Requirements

Regulatory Affairs

Analytical Skills

Documentation

Organizational Skills

Communication

Education

Bachelor’s degree in Regulatory Affairs/Life Sciences/Pharmacy/Engineering/Law/Business

Job description

• Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions to prepare, organize, and file accurate regulatory records.
• Candidates should possess solid knowledge of Regulatory Compliance and Regulatory Requirements to ensure products, services, and processes meet relevant standards and laws.
• Candidates should possess expertise in Regulatory Affairs to coordinate regulatory activities and communicate effectively with regulatory bodies and internal teams.
• Relevant experience in compliance, quality assurance, or legal support within regulated industries (e.g., healthcare, pharmaceuticals, manufacturing, financial services) is highly beneficial.
• Bachelor’s degree in a related field such as Regulatory Affairs, Life Sciences, Pharmacy, Engineering, Law, or Business, or equivalent practical experience.
• Strong analytical, documentation, and organizational skills, with attention to detail and the ability to manage multiple deadlines.
• Effective verbal and written communication skills, and the ability to work collaboratively with diverse teams on-site.
• Familiarity with local Philippine regulations and, ideally, international regulatory frameworks (e.g., FDA, EMA, ISO standards) is a plus.