Regulatory Affairs Officer

5 hours ago

Ayala Alabang, National Capital Region, Philippines GRB Enterprises, Inc. Full time ₱900,000 - ₱1,200,000 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

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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