Lowongan Kerja Cikarang Posisi Regulatory Sr Supervisor di Menarini Group

Info Loker

Perusahaan	Menarini Group
Posisi	Regulatory Sr Supervisor
Tempat	Cikarang
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Farmasi, Layanan Kesehatan
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

POSITION SUMMARY

The Regulatory Affairs is to keep track of the ever-changing legislation in which the company wishes to distribute its products. The regulatory function in healthcare industries is vital in making safety and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is quality assurance is all considered regulatory professionals.

RESPONSIBILITIES

1. Responsible for preparing on registration documents (new product, variation and renewal) for drug, biological product, quasi drug, health supplement, traditional medicine, cosmetic, food, and medical device

2. Follow up to Local, Regional, and/or Partner for required documents for product registration and Additional Data requests

3. Review registration documents compared to Health Authority requirements

4. Support to Regulatory Affairs Manager in submission and getting approvals

5. Follow up status of product’s registration submission

6. Proposing technical solutions to address regulatory requirements or Additional Data from Health Authority

7. Maintain communication with to Local, Regional, and/or Partner for fulfillment of additional data required by Health Authorities

8. Update with Health Authority Regulation

9. Conduct submission for advertisement of OTC products

10. Having experience on 2d Barcode serialization and Halal certification

QUALIFICATION

• Education: Apothecary.

• Experiences: Minimum 5 years relevant experience in regulatory and quality for wholeseller distributor

• Deep understanding of dossier preparations and regulatory affair

• Proficient in English both oral and writing to collaborate with regional and /or corporate related functions

• Good analytical thinking and strong communications

• Having Pharmacist License and Pharmacist Working Permit License

KEY RESULT AREA

• Quality of knowhow about product registration activities
• Quality of strong communication skills with Health Authorities officers
• Quality and timeliness of monthly reporting
• Strong knowledge of Quality, Halal, OSS, Local Content
• Effectiveness of internal control procedures
• Integrity and the ability to inspire trust and confidence of its products

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: Kesehatan/Medis
• Ukuran Perusahaan: 51 - 200 pekerja
• Waktu Proses Lamaran: 29 hari
• Tunjangan dan Lain-lain: Asuransi Gigi, Asuransi kesehatan, Waktu regular, Senin - Jumat, Bisnis (contoh: Kemeja)