Regulatory Affairs Officer Jobs

We are looking for a Regulatory Affairs Specialist to help us ensure all beauty products are meeting all the applicable regulations in Indonesia, especially related to BPOM. Collect and submit to local authority’s documents required for license and renewals following strict deadlines. Follow-up and set timelines for approvals. Protect Brands from any regulatory risk of non-compliance. Monitor existing and new regulations to anticipate any business impact. Attend seminars and meeting with local authorities/associations (as and when needed).

Responsibilities:

• Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.
• Maintains and demonstrates an expert level knowledge and skill in products, quality systems, processes, and regulations.
• Develop and execute local, innovative regulatory strategies that will ensure compliance with local regulations.
• 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.
• 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.
• Support and/or lead challenging communication situations internally or with external agencies/regulators to ensure business outcomes.

Requirements:

• Able to join ASAP
• Preferable with minimum 1-year of working experience in regulatory areas
• Have knowledge in BPOM
• Have knowledge in custom clearance would be a plus point
• Graduate with degree (Bachelors/Masters) in Pharmacy or related field
• Fluent in English both oral and written
• Good connection with local authority and/or regulatory officer