Regulatory Affairs Executive

Description

BUSINESS PARTNER 

Liaise with Global Regulatory Affairs to obtain the needful documents / requirements to ensure timely submission and approval of products registration with Indonesia authority, e.g. BPOM and Ministry of Health 

Liaise with Affiliate Demand Planner and Brand team to track all product registration request and schedule submission accordingly to meet NPL timing 

Track and manage all product registration approval, prepare renewal of product registration schedule to ensure validity continuity for all in-market products 

Proactive external engagement to create and sustain competitive advantage  

Connect with Supply Chain to ensure product label comply with local regulation 

Connect with Brand team to ensure product claim comply with local regulation 

Report and monitor progress of all issues arises from product registration process, escalate for timely resolution. 

SELF DEVELOPMENT 

Act with integrity-honor commitments and takes responsibility for solution recommendation 

Build collaborative relationship to strive operational excellence with internal and external stakeholders  

Demonstrate learning agility in acquiring new knowledge and understanding the working relationship across functions 

Have a positive mindset and be proactive in driving operational change 

Qualifications

Minimum Bachelor's degree in Pharmacy and have 3 years of experience in regulatory affairs, with hands-on experience in FDA product registration.
Experience in the retail or FMCG industry is preferred.
Basic understanding of the country's economic, political, social, cultural, and business environment.
Strong interpersonal skills with the ability to listen, analyze, and communicate diplomatically.
Excellent verbal and written communication skills in English.
Adaptable and open to changes in processes and business needs.
Knowledge of and experience working with vendors in developing countries is an advantage.
Flexible, positive, open-minded, highly organized, detail-oriented, and able to work with accuracy.