Regulatory Affairs Executive

Job Summary

Liaise closely with Global Regulatory Affairs team on all local product registration requests for filing to the authority, e.g. Indonesia Food and Drug Agency (BPOM), Ministry of Health and proactively identify and communicate any challenges encountered related to the OSS system in BKPM. Manage the entire end-to-end process of product registration and product information files (PIF) for all products including planning, execution and tracking, meeting new product launch timeline and maintaining the registration validity approval (includes both new and renewal). Ensure product claim and labeling meeting the requirement before placing product in the market.

Responsibilities

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

Requirements

• Experience in retailing corporations or FMCG is preferable

• Basic understanding of the country’s economic, political, social, cultural & business issues.

• Diplomacy with strong listening and analyzing skills

• Good oral and written communication skills

• Willingness and openness to change processes

• Knowledge of vendors in developing countries is an advantage

• Flexible, positive, open-minded, very structured and precise

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