Regulatory Affairs Manager and Pharmacist

2 weeks ago

San Juan, National Capital Region, Philippines Omnibus Bio-Medical System, Inc. Full time ₱400,000 - ₱600,000 per year

Key Duties and Responsibilities:

  • Regulatory Submissions: Prepare, review, and submit product registration

applications for medical devices, diagnostic reagents, and medical equipment to the Philippine FDA.

  • Compliance Monitoring: Ensure that all products comply with the regulatory

requirements of the Philippine FDA, including standards for safety, efficacy, and labeling of medical devices and machines.

  • Product Documentation: Maintain and update technical documentation, product

dossiers, and ensure timely submission of regulatory documents and reports.

  • Liaison with FDA and Authorities: Serve as the primary point of contact with

the Philippine FDA and other regulatory bodies to facilitate product approvals, renewals, and post-market surveillance activities.

  • Regulatory Strategy: Develop and implement regulatory strategies to optimize

registration timelines and ensure smooth market access for new and existing products.

  • Cross-functional Collaboration: Work closely with the R&D, Quality Assurance,

and Marketing teams to ensure all products meet regulatory requirements throughout their lifecycle.

  • Training and Updates: Stay informed on changes in local and international

regulations and provide regulatory training and updates to internal teams. Skills and Qualifications:

  • Licensed Pharmacist in the Philippines.
  • Minimum of 5 to 10 years of experience in regulatory affairs, specifically

with medical devices, reagents, or machines or in similar industry.

  • In-depth knowledge of Philippine FDA regulations related to medical devices,

diagnostic reagents, and medical equipment.

  • Strong understanding of product registration processes and post-market

compliance.

  • Excellent communication and interpersonal skills to liaise with regulatory

bodies and internal teams.

  • Detail-oriented, with strong organizational and project management abilities.

Job Type: Full-time

Pay: Php40, Php50,000.00 per month

Benefits:

  • Opportunities for promotion
  • Paid toll fees
  • Paid training
  • Promotion to permanent employee

Ability to commute/relocate:

  • San Juan (National Capital Region): Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Required)

Experience:

  • Regulatory Affairs Manager: 5 years (Required)

License/Certification:

  • Pharmacist (Required)

Willingness to travel:

  • 75% (Preferred)

Work Location: In person

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