Senior Regulatory Affair (Apoteker)

Job description

• Develop regulatory strategies for market entry, licensing, and product registration.
• Conduct regulatory gap analysis and compliance assessments.
• Prepare regulatory timelines and project plans.
• Manage end-to-end regulatory submissions for Cosmetic Product; Medical Devices; Food Product Registration; inclusive to Reviewing technical documents, Preparing submission dossiers, Coordinating document legalization when required.
• Act as the primary liaison with relevant government agencies
• Manage multiple client projects simultaneously.
• Monitor new regulations and policy updates.
• Ensure all submissions comply with applicable regulations.
• Develop and improve Standard Operating Procedures (SOPs).

KPI

• Achieve at least 95% on-time completion of all assigned regulatory projects.
• Ensure all regulatory submissions are submitted before the agreed client deadline.
• Monitor project timelines and proactively escalate potential delays.
• Ensure all submission dossiers are complete, accurate, and compliant before submission.
• Monitor new and updated regulations relevant to client industries.
• Effectively manage multiple regulatory projects simultaneously.
• Identify potential regulatory risks at an early stage.
• Maintain professional competency by participating in regulatory training and seminars.

Any specific skills, experience, or education requirement

• Bachelor's Degree (S1) in Pharmacy.
• Willingness for its Indonesian pharmacist license (STRA) to be used as PJT (Company Representative for BPOM
• Additional certifications in Regulatory Affairs, Quality Management, or Project Management are an advantage.
• Minimum 3 years of experience in Regulatory Affairs, preferably within a regulatory consulting firm, pharmaceutical company, cosmetic company, medical device company, or healthcare industry.
• Experience managing multiple regulatory projects simultaneously.
• Experience communicating and coordinating directly with government authorities.