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Unilab, Inc.

Regulatory Affairs Specialist  

Unilab, Inc.

 
  • Mandaluyong, Philippines
    66 , United St, Highway Hills, Mandaluyong, Metro Manila, Philippines
    Mandaluyong
    Metro Manila
    Philippines
    Philippines
  • Penuh waktuFULL_TIME

Lowongan dipasang 22 days ago dan batas waktu lamaran adalah 19 Jun

Rekruter terakhir aktif 12 days ago

2025-04-21T06:07:04.702189+00:002025-06-19T16:00:00+00:00

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
Industri
Pharmaceuticals
Lowongan
1 lowongan dibuka
Situs
https://careers.unilab.com.ph

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Tentang Unilab, Inc.

Unilab is the leading pharmaceutical company in the Philippines, and it remains to be a strong industry leader distinguished by its values of Husay, Malasakit at Bayanihan. Currently, Unilab is home to more than 300 brands of affordable top-quality products in all the significant therapeutic categories, such as prescription drugs, consumer healthcare, and personal care products. We care for millions of Filipinos with trusted brands such as Biogesic, Enervon, Neozep, Alaxan, Bioflu, Myra-E, Ceelin, and others. Lead with Purpose. Experience Alagang Unilab. For 80 years, Unilab has remained steadfast in its purpose: to build a healthier Philippines, one quality medicine at a time. Guided by our deeply rooted values of Husay at Malasakit and the spirit of Bayanihan, we continue to serve Filipino communities by providing them trusted quality healthcare. At the core of everything we do is Alaga—the heart of our brand and culture. We ensure that our people genuinely feel this care, so they can extend the same compassion and commitment to the communities we serve, making quality healthcare more accessible to every Filipino. We believe that when our people feel genuinely cared for, they are empowered to care more deeply for others. That’s why we invest in our people through meaningful work, continuous learning, supportive leadership, holistic well-being, and a collaborative environment. When you join Unilab, you don’t just build a career—you lead with purpose. You create real impact by delivering quality healthcare to Filipinos, and in the process, you also experience Alagang Unilab—through personal growth and professional development.

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