Regulatory Affairs Executive
PT Kalventis Sinergi Farma
- Penuh waktu
- Hybrid • Cirebon
- Negotiable
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Deskripsi Pekerjaan
Job & Responsibilities:
- To prepare, review, and compile registration dossier based on company data file or applicable standard in accordance to local Health Authority requirements.
- Prepare administrative document (such as covering letter, statement letter, payment etc.) for registration submission to local Health Authority.
- Submit the registration document to local HA in timely manner.
- To do verification active and inactive material, manufacturer in local HA database; follow up of verification and technical issue related e-registration system to local HA.
- Follow the registration submission status in local HA application system.
- Ensuring all information and data in company database are updated.
- Communicate deficiency/any queries from local HA to principal.
- Submit Response for deficiency in timely manner.
- Keep updated with new regulatory policies.
- Maintain accuracy of product labeling to comply with the global and local requirement.
- Ensure appropriate training has been conducted.
- To support and assist Regulatory Affairs Manager as necessary.
Kualifikasi
Qualifications & Requirements:
- Bachelor's degree in Pharmacy/ Pharmaceutical Sciences. Having a Pharmacist degree is much preferred.
- Specialized courses or certifications in regulatory affairs would be advantageous.
- At least 3-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology industry.
- Hands-on experience with compiling registration dossiers, submission processes, and interacting with Health Authorities.
- Prior experience in maintaining product labeling to comply with global and local requirements is desirable.
- Comprehensive understanding of local and international regulatory requirements and guidelines related to pharmaceuticals
- Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Knowledge and adherence to relevant laws, regulations, and guidelines governing the pharmaceutical, biotechnology, or medical device industry.
- Experience in ensuring compliance with regulatory requirements throughout the product lifecycle, including registration, post-market
Tips Menjaga Diri
Perusahaan dan Lowongan di Dealls tidak meminta data pribadi, informasi rekening, atau pungutan ketika melamar. Hindari juga lowongan Google Form / Grup Telegram tanpa keabsahan yang jelas.
Kami dengan bangga mengumumkan peluncuran entitas baru kami PT Kalventis Sinergi Farma (sebelumnya Sanofi Indonesia), membawa inovasi baru ke pasar lokal dan bertujuan untuk menjadi pemain utama secara global. Kami berkomitmen untuk mengembangkan produk dan layanan yang memenuhi kebutuhan pelanggan di seluruh dunia, menciptakan lingkungan kerja yang mendukung dan menantang bagi tim berbakat kami. Dengan kerja keras dan dedikasi, kami bersemangat untuk membangun perusahaan yang berkembang dan menjadi pemimpin di industri ini, menyambut talenta terbaik untuk bergabung dalam perjalanan kami.
