

Regulatory Affairs Specialist
Unilab, Inc.
- Mandaluyong, Philippines66 , United St, Highway Hills, Mandaluyong, Metro Manila, PhilippinesMandaluyongMetro ManilaPhilippinesPhilippines
- Penuh waktuFULL_TIME
Deskripsi Pekerjaan
Regulatory
• Prepares and submits product registration dossiers to the Philippine FDA.
• Evaluates dossiers for quality and completeness.
• Prepares and submits product registration dossiers to export country affiliates/distributors.
• Maintains Licenses to Operate and Certificates of Foreign Good Manufacturing Practice with the FDA.
• Handles promotional permit applications and submits to the FDA.
• Coordinates with regulatory agencies on registrations, variations, and permits.
• Manages product information in various databases.
• Prepares and reviews procedural documents for FDA submissions and commercial orders.
• Ensures valid processes for packaging transitions.
• Provides customer support for product inquiries and transport documents.
Medical - Strategic Marketing Support:
• Handles packaging artworks for product registration or promotions.
• Manages pharmacovigilance activities and reports adverse events to the FDA.
• Coordinates quality-related complaints and suspected counterfeit products.
• Supports marketing efforts with necessary documents.
Medical Education Programs:
• Prepares educational materials for divisional programs.
• Implements medical training for personnel and partners.
Advertising Claims Support:
• Researches and provides medical information for product claims and brand communication.
• Reviews and updates packaging text for relevant claims.
• Assists in filing complaints against competitor products.
• Coordinates product inclusion in medical directories (MIMS, PPD).
Kualifikasi Minimum
- Graduate of a Bachelor’s Degree in Pharmacy
- Must be a licensed pharmacist
- With 3 to 6 years of experience in regulatory and/or medical affairs
- Knowledgeable in FDA guidelines and medical information
- Must have good interpersonal skills and able to work well independently
- With keen attention to detail, and has the ability to multi-task and meet strict deadlines
Ringkasan Perkerjaan
- Tingkat Posisi
- Lulusan Baru / Junior
- Spesialisasi
- Sciences
- Persyaratan tingkat pendidikan
- Lulus program Sarjana (S1)
- Alamat Kantor
- United Street
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