Regulator Affairs Pharmacist

2 days ago

Pasig, National Capital Region, Philippines Scriptmed Inc. Full time $40,000 - $60,000 per year

The ideal candidate will ensure compliance of Scriptmed Inc.'s pharmaceutical and healthcare products with all applicable regulatory requirements, from product registration to post-marketing surveillance. They will serve as the liaison between the company and regulatory authorities, preparing, submitting, and monitoring documentation to secure product approvals. The role also involves staying up to date with evolving regulations, ensuring that company processes align with industry standards, and supporting the product life cycle from a compliance perspective.

Responsibilities

  • Prepare, review, and submit regulatory documents for product registration, renewal, variation, and other approvals.
  • Ensure compliance of product labels, packaging, and promotional materials with relevant laws and regulations.
  • Liaise with the Food and Drug Administration (FDA) and other regulatory bodies to address queries, requirements, and inspection findings.
  • Maintain up-to-date knowledge of local and international pharmaceutical regulations and guidelines.
  • Monitor product safety through adverse event reporting and pharmacovigilance activities.
  • Maintain organized regulatory files and databases for all submissions and approvals.
  • Collaborate with cross-functional teams, including marketing, sales, and supply chain, to ensure timely regulatory support for product launches and changes.
  • Participate in internal audits and assist in preparing for regulatory inspections.
  • Provide regulatory advice and training to internal teams to support compliance culture.

Qualifications

  • Licensed Pharmacist in the Philippines.
  • At least 1–2 years of experience in Regulatory Affairs, preferably in the pharmaceutical or healthcare industry.
  • Strong knowledge of local FDA processes, cGMP guidelines, and related regulatory requirements.
  • Excellent attention to detail and organizational skills.
  • Strong communication and interpersonal abilities for effective coordination with internal teams and regulators.
  • Ability to manage multiple submissions and projects simultaneously.
  • Responsible for supervising warehouse operations, ensuring compliance with regulatory standards, proper storage conditions, and accurate inventory management.
  • Proficiency in Microsoft Office and basic database management.

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