Regulatory Affairs & Export (Contract)

PURPOSE

The purpose of this role is to support the Local Regulatory Affairs team in regulatory activities related to product life cycle management for the Consumer Health Division. This includes registration and maintenance of export licenses, export certificates, the legalization process, and interaction with relevant government bodies to ensure the continuity of the Cimanggis site’s export business.

MAJOR TASKS

Local Business

Product Life Cycle and Advertisement Registration Management

Support the Regulatory Affairs Associate Manager in all regulatory activities for product license maintenance, including renewal and minor variations as per product portfolio designation. Responsibilities include, but are not limited to:

• Compiling and reviewing registration dossiers, including responding to Deficiency Letters from Health Authorities, and conducting pre-submission consultations if necessary.
• Performing the submission process to Health Authorities for assigned products/projects.
• Monitoring and following up on registrations until approval is obtained.
• Coordinating with Global/Local Regulatory Project Leads to collect additional documents requested by Health Authorities via Deficiency Letters and ensuring proper documentation in the system.

Export

1. Export License Management

   • Responsible for registration and maintenance (renewal and variation) of export licenses for Cimanggis site export activities and NPD projects, in accordance with local regulations and internal Bayer SOPs. Tasks include:
     • Pre-submission: Initial assessment, communicating requirements, receiving, compiling, and reviewing dossiers for submission.
     • Submission into the BPOM online system for new licenses and license maintenance (renewals and variations).
     • Following up and addressing any Deficiency Letter requests.
     • Receiving approvals and communicating with all stakeholders.
     • Archiving and maintaining the license database.

2. Export Certificate Management

   • Responsible for registration and legalization of export certificates required for Cimanggis site export and/or import activities, as well as NPD projects. Tasks include:
     • Pre-submission: Initial assessment, communicating requirements, receiving, compiling, and reviewing dossiers for submission.
     • Submission into the BPOM online system.
     • Following up and addressing any Deficiency Letter requests.
     • Receiving certificate approvals and communicating with stakeholders.
     • Performing notarization and legalization processes as required, including submissions to the Ministry of Law, Ministry of Foreign Affairs, Chamber of Commerce, and the Embassy of the exporting country.
     • Managing the shipment of documents to export markets.
     • Archiving and maintaining the export tracker.

3. Coordination

   • Coordinate with the Global Regulatory Project Lead, Affiliate Specialist, and relevant functions in the Cimanggis site, such as NPD project leads and local Regulatory Affairs from export markets, to fulfill requirements within timelines. This includes managing variations of export licenses related to NPD projects, change requests, or regulatory changes.

4. Meetings

   • Attend regular meetings with the Global Affiliate Specialist to track requests and manage timelines.

SKILLS & REQUIREMENTS

• Bachelor's degree in Pharmacy.
• At least 1 year of experience with export document registration at BPOM and registration/legalization procedures for export certificates (CFS, CPP, GMP Cert., etc.).
• Strong communication skills with proficiency in English.