Senior Regulatory Affair (Apoteker)

PT Emerhub Consulting Indonesia; Jakarta Utara; On-site; IDR 200,000,000 - 320,000,000; Full time

Job summary

PT Emerhub Consulting Indonesia is seeking an experienced Regulatory Affairs professional to lead regulatory strategies for market entry, licensing, and product registration across cosmetics, medical devices, and food products. You will manage end-to-end submissions, coordinate with government authorities, and develop SOPs while monitoring regulatory changes.

The role requires at least 3 years in Regulatory Affairs, a Pharmacy degree, and willingness to use STRA for BPOM representation.

Qualifications

• Bachelor's Degree (S1) in Pharmacy.
• Willingness for STRA license 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.
• Experience communicating and coordinating directly with government authorities.

Responsibilities

• 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.
• Monitor new regulations and policy updates.
• Ensure all submissions comply with applicable regulations.
• Develop and improve Standard Operating Procedures (SOPs).
• Identify potential regulatory risks at an early stage.

Skills

Regulatory coordination

Project management

Stakeholder liaison

Regulatory submissions

Education

Bachelor's Degree in Pharmacy

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 elevate 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.

Emerhub was founded in Jakarta in 2011. Since then we have been providing complete solutions for investors around the world to enter and thrive in South East Asia. Our mission is to lower entry barriers in the emerging markets, We believe to do so, We contributing to creating a better, more accessible world. Our Jakarta office is expanding and we need You to join our team!

Emerhub was founded in Jakarta in 2011. Since then we have been providing complete solutions for investors around the world to enter and thrive in South East Asia. Our mission is to lower entry barriers in the emerging markets, We believe to do so, We contributing to creating a better, more accessible world. Our Jakarta office is expanding and we need You to join our team!