Regulatory Affairs Specialist

2 weeks ago

Ayala Alabang, National Capital Region, Philippines GRB Enterprises, Inc. Full time ₱30,000 - ₱60,000 per year

Responsibilities:

  • Deals with and takes care of regulatory issues and carries out the plan to make sure the company complies with regulations
  • Establishes procedures and systems to make sure that all required filings, certifications, and permits are completed and kept track.
  • Collate, Prepare registration requirements and Liaise with respective regulatory agencies in securing appropriate License and Product Registration.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Documenting the product classifications that need regulations and protocols.
  • Ensures that company's products comply with the regulations of the regions where they should be distributed (BFAD, PEDEA, FDA, CNDM, PMPIN, etc.)
  • Prepares and submits applications and reports to applicable regulatory agencies.
  • Ensures that quality standards are met and submissions meet strict deadlines
  • Remain current with regional, national, and worldwide laws, regulations, and consumer behavior
  • Examines business practices and procedures and offers suggestions for system improvements
  • Coordinates and liaises for timely, effective, ethical, and strategic adherence to local regulatory requirements
  • Assures orderly filing, thoroughness, confidentiality, adherence to the companies' standards, and readiness for local audits.
  • To review, analyze, prepare and assemble regulatory documents needed per shipment.
  • Ensures product information, permits and licenses are updated and accessible.
  • Assisting the IMPEX on the shipments related concerns
  • Maintain the updated files of product registration and regulatory compliance documents.
  • Coordination with the the ImpEx Officer.
  • Secure licenses and certificate of the company. (e.g., BOC Permit, BFAD, FDA, etc.,)
  • Ensure that quality standards are met and submissions meet strict deadlines.
  • Performs other related duties as required and assigned.
  • Support Individual department heads on creation/update on their SOP and Policies.

Qualifications:

  • Graduate of BS in Pharmacy or other related courses.
  • Relevant work experience is preferred but not required
  • Excellent written and verbal communication skills
  • Good coordination skills and keen attention to details
  • Must be a team-player and understands the role as part of a bigger group and knows how the job integrates with that of other teams and departments in achieving a common goal.
  • Proficient in MS applications
  • Attentive to detail and maintain an organized work environment.
  • Strong decision-making and leadership capability, and a team-player
  • Can work under pressure with minimum supervision and with self-initiative
  • Amenable to work onsite in Alabang, Muntinlupa City

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