Senior CMC Regulatory Strategy Manager - Pharmaceuticals (Remote from Bali)

GSK · 📍 Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, Badung · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
IDR 800000000 - 1200000000
GSK is seeking a highly skilled and experienced Senior CMC Regulatory Strategy Manager to join our team. This role offers the opportunity to work remotely from Bali while contributing to the global pharmaceutical industry. The ideal candidate will have a strong background in CMC (Chemistry, Manufacturing, and Controls) and regulatory affairs, with a deep understanding of international regulations and standards.

📋 Tanggung Jawab Pekerjaan

Develop and implement CMC and regulatory strategies to ensure compliance with global regulations.,Lead and mentor a team of regulatory affairs professionals.,Provide technical guidance and support to ensure the quality and compliance of our products.,Collaborate with cross-functional teams to drive innovation and improve processes.,Monitor regulatory trends and developments, and advise on potential impacts and opportunities.,Ensure timely and accurate submission of regulatory filings and reports.,Conduct risk assessments and develop mitigation strategies to address regulatory challenges.

🎓 Kualifikasi & Syarat

Bachelor's degree in Pharmacy, Chemistry, or a related field.,10+ years of experience in CMC and regulatory affairs, with at least 5 years in a leadership role.,Strong knowledge of international regulations, including ICH guidelines and FDA, EMA, and PMDA guidelines.,Proven track record of successful regulatory submissions and approvals.,Excellent communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.,Proficiency in English, both written and spoken.

🛠️ Keahlian

Regulatory affairsCMC (ChemistryManufacturingand Controls)Risk assessment and mitigationProcess improvement and innovationTeam leadership and mentoringRegulatory compliance and reporting
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