Senior CMC Regulatory Strategy Manager

GSK · 📍 Canggu,Ubud,Denpasar,Jimbaran,Nusa Dua,Kuta,Badung · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
USD 80000 - 120000
GSK is seeking a highly experienced Senior CMC Regulatory Strategy Manager to join our team in Indonesia. This role is crucial in shaping and implementing our CMC (Chemistry, Manufacturing, and Controls) regulatory strategies to ensure compliance with local and international regulations. The ideal candidate will have a strong background in regulatory affairs and a proven track record in managing complex regulatory projects.

📋 Tanggung Jawab Pekerjaan

Develop and implement CMC regulatory strategies in alignment with GSK's global standards and local regulations.,Lead and manage regulatory projects, ensuring timely and accurate submission of regulatory filings.,Collaborate with cross-functional teams to ensure regulatory compliance across all manufacturing sites.,Provide strategic advice on regulatory risks and opportunities to senior management.,Monitor regulatory trends and developments, and advise on their potential impact on business operations.,Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.,Develop and maintain strong relationships with regulatory authorities and external stakeholders.

🎓 Kualifikasi & Syarat

Bachelor's degree in Pharmacy, Regulatory Affairs, or a related field.,Minimum of 8 years of experience in regulatory affairs, with at least 5 years in a senior management role.,In-depth knowledge of Indonesian and international regulatory requirements for pharmaceuticals.,Strong understanding of GMP, GCP, and other relevant regulatory guidelines.,Excellent leadership and project management skills.,Proven ability to work effectively in a multicultural and diverse environment.,Strong communication and interpersonal skills.,Proficiency in English is required; local language proficiency is a plus.

🛠️ Keahlian

Regulatory Strategy DevelopmentRegulatory Project ManagementGMP and GCP ComplianceRegulatory Risk AssessmentStakeholder ManagementRegulatory Affairs Software Proficiency
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