Regulatory Pharmacist

14 hours ago

Pasig, National Capital Region, Philippines JLT Pharma Inc. Full time ₱25,000 - ₱600,000 per year

Job Description

  • Serves as a point of contact and coordinates with regulatory authorities, local and international clients regarding the preparation of documents for product registrations, renewals, compliances, variations and other regulatory matters.
  • Review, and submit regulatory dossiers (e.g., CTD, eCTD, ACTD) and requirements to regulatory agencies for new product registrations, renewals, compliances and variations.
  • Ensure timely approvals and renewals by communication to regulatory authorities relative to company and product registrations, follow ups and compliances.
  • Responsible for preparing the necessary documents for applying GMP clearance of manufacturers to local regulatory authority.
  • Maintain product registration files and regulatory databases.
  • Interpret and ensure up-to-date compliance of regulatory requirements, guidelines, and legislation (WHO, ICH, FDA, EMA, MHRA and local health authorities)
  • Ensure compliance of product labeling, packaging, and advertising with regulatory standards.
  • Ensure pharmacovigilance compliance according to regulatory requirements.
  • Provide regulatory guidance to support strategic business and product decisions.
  • Responsible for the application, renewal and filing of Trademark of products with IPO

Qualifications:

  • Candidate must possess a Bachelor's/College Degree in Pharmacy
  • Must have a valid PRC ID for Pharmacist
  • Must be able to multitask and work under pressure
  • Must possess good communication and organization skills
  • Must be able to communicate well in English
  • Goal-driven, self-motivated and with high sense of responsibility, commitment and integrity
  • Required Skills: MS Excel, MS Word, Powerpoint, Adobe Illustrator

We offer:

  • Most favorable working conditions
  • Highest incentive system extra salary
  • Experience overseas business trip to Korea
  • Experience for various educations and seminars

Working Hours:

  • Monday-Thursday: 8:00 AM to 5:00 PM
  • Wednesday: Work From Home (WFH)
  • Friday: 8:00 AM to 4:00 PM

Job Types: Full-time, Permanent

Pay: Php25, Php60,000.00 per month

Benefits:

  • Company Christmas gift
  • Health insurance
  • Paid training
  • Work from home

Work Location: In person

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