Regulatory Affairs Pharmacist

2 days ago


Caloocan City, National Capital Region, Philippines CALA Consumer Products Manufacturing Corp. Full time

Regulatory Compliance:

  • Ensure company products comply with applicable regulatory standards (FDA, IPO, etc.).
  • Prepare, review, and submit regulatory filings, such as licenses, and certifications.
  • Monitor and keep up to date with changes in regulations, industry standards, and compliance requirements.
  • Act as the primary point of contact with regulatory authorities and auditors, managing external inspections and audits.
  • Ensure compliance with labeling, packaging, and documentation requirements for all products.

Quality Control:

  • Develop and implement quality control protocols and procedures for incoming materials, in-process production, and finished products.
  • Perform inspections, testing, and sampling of materials and products to ensure they meet established quality standards.
  • Collaborate with production teams to troubleshoot quality issues and implement preventive measures.
  • Maintain and calibrate QC equipment and ensure testing environments are in compliance with required standards.

Documentation and Reporting:

  • Maintain and organize records of QC inspections, test results, and regulatory submissions.
  • Draft, review, and update quality and regulatory documentation, such as Standard Operating Procedures (SOPs), product specifications, and certificates of analysis (CoAs).
  • Prepare and present reports on product quality and regulatory compliance to senior management.

Qualifications:

  • Bachelor's degree in Pharmacy or any related courses.
  • At least 1 year of experience in regulatory affairs, quality assurance, or a related role.
  • In-depth knowledge of regulatory requirements for the specific industry (cosmetics, food, etc.).
  • Experience with quality systems such as GMP or similar.
  • Strong attention to detail and organizational skills.
  • Excellent communication and interpersonal skills to collaborate with internal teams and regulatory bodies.
  • Ability to work independently and manage multiple priorities.

Job Type: Full-time

Pay: Php25, Php30,000.00 per month

Benefits:

  • Employee discount
  • On-site parking

Work Location: In person



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