Lowongan Regulatory Affairs Manager di PT Satu Dental Indonesia

• Ensure timely approvals of new clinics, product permits, and renewals
• Develop and manage clinic and product registration strategies in line with company goals
• Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country
• Develop and maintain good and professional relationships with appropriate regulatory agencies to ensure a smooth and efficient registration process (i.e BPOM, DINKES,etc)
• With guidance, contribute to global regulatory strategies, considering local regulation and business needs
• Provide regulatory affairs advice into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
• Ensure good filing system both softcopies and hardcopies including keeping the document in secured place (clean desk policy) are well implemented
• Coordinate with the plant or sourcing team to request and obtain all requirement documents for registration (Local, Import, Export)
• Always update the new regulation to company which will impact to the business continuity
• Open for business travel around Indonesia

Requirement:

• University degree (BS or Master) with related disciplines
• 3-4 years working experience in the health regulatory affairs field
• Familiar with Indonesian clinics, drugs, medical devices and cosmetics registration procedures and regulatory aspects
• Analytical skills and attention to detail with the capability to appropriately define issues, questions and data
• Good, positive and proactive communication and the ability to foster excellent working relations with external customers
• Good relationship and extensive networking with BPOM, DINKES, MUI, etc.