Regulatory Affairs Spv
PT Darya-Varia Laboratoria Tbk
- Penuh waktu
- On-site • Jakarta Selatan
- Negotiable
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Deskripsi Pekerjaan
- Execute & monitoring product registration process
- Coordination with related department and Principal, review docs & prepare good registration dossier.
- Ensure all regulatory activities (new product, variation & renewal submission) are compliant with regulations, requirements and practices.
- Ensure to get approval as committed timeline
- Liaise with Manager & Dept. Head to get advises on regulatory strategy and approach.
- Develop good relations with internal & external stake holders
Kualifikasi
- Has experience in regulatory affairs min 2 years for drug product registration
- Knowledge of the local regulatory affairs environment and how this impacts regulatory strategy and implementation, especially related to product registration requirement, regulation & quidelines.
- Strong communication and interpersonal skills.
- Detail-oriented with the ability to manage projects from inception through execution and tracking progress of projects to completion
- Proficiency in English both, written and spoken
- Good communication & negotiation skill
- Loyal & has a good responsibility, good teamwork
- Positive attitude
- Fast learning
- Proficiency in English both, written and spoken
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PT Darya-Varia Laboratoria Tbk (“Darya-Varia”) was established in 1976 as a domestic investment pharmaceutical company. In November 1994, Darya-Varia listed its shares on the Indonesia Stock Exchange (IDX) with the stock ticker code of DVLA. Currently, Darya-Varia operates two manufacturing plants in Gunung Putri and Citeureup that have met the international standards of current Good Manufacturing Practice (c-GMP) and standards set by the National Agency of Drug and Food Control (BPOM). Darya-Varia always ensures the quality and safety of each product. All products of the Company are halal certified. All plant facilities owned by Darya-Varia have implemented the halal assurance system.
