Regulatory Affairs Officer

Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.

Develop and execute local, innovative regulatory strategies that will ensure compliance with local regulations.

Advise on regulatory intelligence, governance, best practices, and process improvements. Support product development activities and in accordance with enterprise or business launch plans.

Prepare and/or advise others on preparation of regulatory submissions for introduction of novel products in accordance with BPOM requirements.

Advise on applicability of new or proposed legislation changes on marketed products and the innovation pipeline, communicating these developments to senior Innovation, functional or business leaders.

Support and/or lead challenging communication situations internally or with external agencies/regulators to ensure business outcomes.

Maintains and demonstrates an expert level knowledge and skill in products, quality systems, processes, and regulations.
Graduate with degree (Bachelors/Masters) in Pharmacy or related field

Preferable with minimum 1-year of working experience in regulatory areas

Good connection with local authority and/or regulatory officer

Have knowledge in BPOM

Have knowledge in custom clearance would be a plus point

Fluent in English both oral and written

Able to join ASAP