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.