Senior CMC Regulatory Strategy Manager - Pharmaceutical & Life Sciences

GSK · 📍 Bali, Indonesia (Remote options for Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, Badung) · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
USD 120000 - 180000
GSK is seeking a highly skilled and experienced Senior CMC Regulatory Strategy Manager to join our team in Bali, Indonesia. This role offers a unique opportunity to work in a dynamic and innovative environment, contributing to the development and implementation of regulatory strategies for our pharmaceutical and life sciences products. The ideal candidate will have a strong background in regulatory affairs and a passion for driving excellence in product quality and compliance.

📋 Tanggung Jawab Pekerjaan

Develop and implement regulatory strategies to ensure compliance with local and international regulations.,Lead and mentor a team of regulatory affairs professionals to drive continuous improvement in regulatory processes.,Collaborate with cross-functional teams to ensure the timely submission of regulatory filings and approvals.,Monitor regulatory trends and developments to proactively address potential risks and opportunities.,Provide expert advice and guidance on regulatory requirements and best practices to internal stakeholders.,Build and maintain strong relationships with regulatory authorities and external stakeholders.,Ensure the timely and accurate preparation of regulatory submissions and documentation.,Conduct regular audits and reviews to ensure compliance with regulatory requirements.

🎓 Kualifikasi & Syarat

Bachelor's degree in Pharmacy, Regulatory Affairs, or a related field.,Minimum of 10 years of experience in regulatory affairs, with at least 5 years in a senior management role.,Strong knowledge of regulatory requirements for pharmaceutical and life sciences products in Indonesia and other relevant markets.,Proven track record of successfully managing regulatory projects and achieving regulatory approvals.,Excellent leadership and communication skills, with the ability to influence and inspire a team.,Strong analytical and problem-solving skills, with the ability to think strategically and proactively.,Proficiency in English, both written and spoken.,Experience with regulatory software and tools is a plus.

🛠️ Keahlian

Regulatory affairs expertiseLeadership and team managementStrategic thinking and planningRegulatory compliance and risk managementStakeholder managementRegulatory software proficiency
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