Regulatory Affairs Officer
5 hours ago
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
Training & Certifications
Honest and trustworthy.
Can work under pressure with minimum supervision and with self-initiative
Amenable to work onsite in Alabang, Muntinlupa City
Job Type: Full-time
Work Location: In person
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