Regulatory Affairs Manager

Talent Insider is an upcoming HR Consultancy Service, founded in 2021. Our clients have been some of the leading brands in Indonesia, and this service continues to expand.

Registered in Singapore & Indonesia, we can assist with your growth plans and strategies, and continue to expand our regional presence with strong regional partners to assist our client in recruitment and branding strategy.

• Responsible For Local Regulatory Submissions Plan
• Contribute To Development Of Regulatory Strategies For New Products And Changes To Existing Products In Line With Business Objectives
• Product Submissions, Registration And Compliance To International Regulatory Standards By Preparation And Submission Of Technical Dossiers (ICH) Or Technical Files To Regulatory Authorities In The Country
• Manage Compilation And Submission Of Responses To Queries Raised During The Evaluation Process Of NDAs Through Coordination With Relevant Parties
• Manage Compliance Of Product Labels And Liaise With Supply Chain For The Implementation In Commercial Shipments In The Country
• Life Cycle Management Of Existing Product Portfolio To Ensure Regulatory Compliance And Licence Renewals To Support Business Needs
• Provision Of Regulatory Advice To Regulatory Colleagues In The Region And Other Colleagues In The Organization
• Collation Of Information From The Region For Periodic Safety Updates Reports
• Responsible For All Regulatory Operations That Involve Liaising Work Within The Company Functions Such As Production, R&D And QA Departments As Well As External Agencies Such As Health Authorities In The Country
• Manage Company Regulatory Affairs Activities Including Reports, License Transfers And Renewals To Ensure Compliance With Government Requirements And Company Standards

• Pharmacy, Science degree or equivalent
• 5-10 years relevant working experience in RA settings in the country, product registrations and life cycle management
• Pharma experience
• Medical device experience a plus
• Quality experience a plus