Senior Regulatory Affairs Specialist (Pharmacist)

RecruitGo ยท ๐Ÿ“ Jakarta Selatan, Jakarta Raya ยท Diposting 2026-10-09
FULL_TIMEโญ TERVERIFIKASI
IDR 9000000 - 12000000
RecruitGo is seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring that our products comply with all relevant regulations and standards. You will work closely with our legal and compliance teams to ensure that our company is in full compliance with all applicable laws and regulations.

๐Ÿ“‹ Tanggung Jawab Pekerjaan

Develop and implement regulatory strategies to ensure compliance with all relevant laws and regulations.,Monitor and analyze regulatory changes and their potential impact on our business.,Prepare and submit regulatory submissions, including new drug applications (NDAs), biologics license applications (BLAs), and other regulatory filings.,Conduct regulatory inspections and audits to ensure compliance with all applicable regulations.,Provide regulatory support to our marketing and sales teams to ensure that our products are marketed and sold in compliance with all applicable regulations.,Develop and maintain relationships with regulatory agencies and other stakeholders to ensure that our company is in good standing with all relevant authorities.

๐ŸŽ“ Kualifikasi & Syarat

Bachelor's degree in Pharmacy or a related field.,Minimum of 5 years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.,Strong knowledge of regulatory requirements and guidelines for pharmaceutical products in Indonesia and other relevant markets.,Excellent written and verbal communication skills in English and Indonesian.,Ability to work independently and as part of a team in a fast-paced environment.,Strong problem-solving and analytical skills.,Professional certification in regulatory affairs (e.g., CQA, QP, RAC) is a plus.

๐Ÿ› ๏ธ Keahlian

Regulatory affairsPharmaceutical regulationsRegulatory submissionsRegulatory inspectionsRegulatory strategyRegulatory complianceRegulatory communications
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