Head of Regulatory Affairs

Pengiklan Anonim; Gunung Putri; On-site; IDR 320,000,000 - 520,000,000; Full time

Job summary

Pengiklan Anonim is seeking an experienced Regulatory Affairs leader to oversee end-to-end strategies for registration and re-registration of biological veterinary products in Indonesia and international markets.

You will manage a regulatory team, ensure compliance with national and international requirements, and coordinate with government authorities to maintain valid licenses and timely submissions.

Qualifications

• Professional Degree in Veterinary Medicine.
• Minimum of 8 years of experience in Regulatory Affairs.
• Fluent in English, both written and spoken.
• Excellent communication and stakeholder management abilities.
• Strong knowledge of veterinary product registration in Indonesia.
• Good understanding of export registration processes and international regulatory requirements.
• Experience in regulatory compliance, dossier preparation, registration submission, license maintenance, renewals, and product variations.
• Familiarity with regulatory authorities and licensing processes for animal health products.
• Ability to work effectively in a dynamic environment with tight deadlines.

Responsibilities

• Manage and coordinate regulatory processes related to the registration, re-registration, and import/export of biological products in domestic and international market.
• Ensure that all products comply with applicable regulatory requirements, standards, and relevant legislation.
• Coordinate the preparation of product samples for testing in accordance with regulatory requirements.
• Facilitate the acquisition of necessary permits, recommendation letters, and supporting documentation required for product registration and distribution.
• Establish and maintain effective communication and coordination with internal teams and relevant regulatory authorities, particularly the Ministry of Agriculture and the Ministry of Marine Affairs and Fisheries.
• Ensure that all product registration processes are conducted efficiently, completed within established timelines, and comply with applicable regulatory requirements.

Skills

Regulatory affairs

Stakeholder management

Communication

English proficiency

Project management

Education

Veterinary Medicine degree

Job description

Manage end-to-end regulatory processes for biological product registration, re-registration, and import/export, ensuring compliance with applicable regulations, timely permit acquisition, product testing, and effective coordination with internal teams and relevant government authorities.

Key Requirements

Professional Degree in Veterinary Medicine

Minimum of 8 years of experience in Regulatory Affairs

Fluent in English, both written and spoken

Excellent communication and stakeholder management abilities

Strong knowledge of veterinary product registration in Indonesia

Good understanding of export registration processes and international regulatory requirements

Experience in regulatory compliance, dossier preparation, registration submission, license maintenance, renewals, and product variations

Familiarity with regulatory authorities and licensing processes for animal health products

Ability to work effectively in a dynamic environment with tight deadlines

Responsibilities

Manage and coordinate regulatory processes related to the registration, re-registration, and import/export of biological products in domestic and international market

Ensure that all products comply with applicable regulatory requirements, standards, and relevant legislation

Coordinate the preparation of product samples for testing in accordance with regulatory requirements

Facilitate the acquisition of necessary permits, recommendation letters, and supporting documentation required for product registration and distribution

Establish and maintain effective communication and coordination with internal teams and relevant regulatory authorities, particularly the Ministry of Agriculture and the Ministry of Marine Affairs and Fisheries

Ensure that all product registration processes are conducted efficiently, completed within established timelines, and comply with applicable regulatory requirements

Job Description

Lead and oversee end-to-end regulatory strategies for the registration and re-registration of biological products across domestic and international markets, ensuring alignment with business priorities and market access objectives

Manage and develop the Regulatory Affairs team, setting clear KPIs, timelines, and compliance standards

Lead regulatory intelligence and maintain up-to-date knowledge of national and international regulatory requirements to ensure compliance with applicable standards and regulations

Lead the management and resolution of regulatory inquiries, requests for clarification, and documentation deficiencies raised by regulatory authorities throughout the registration process

Build and maintain strong relationships with key regulatory bodies, primarily the Ministry of Agriculture and the Ministry of Marine Affairs and Fisheries.

Monitor global and local regulatory changes to ensure ongoing organizational compliance

Drive cross-functional alignment and accountability with TCB, Research and Development (R&D), Quality Assurance (QA), and Production to ensure the timely availability, completeness, and quality of technical documentation and supporting data for regulatory submissions

Track and monitor product registration progress and timelines to ensure the timely submission of all required documentation

Manage the maintenance and updating of existing product registrations, including license renewals and amendments to product specifications, as required

Collaborate closely with relevant regulatory authorities to obtain new product registration numbers and ensure the validity of existing product licenses

Ensure that all product registration documents and supporting data remain accurate, up to date, and compliant with applicable regulatory requirements

Why Join Us?

Strategic leadership role within a leading animal health company.

Opportunity to drive innovation and support business growth.

Exposure to local and international regulatory affairs.

Collaborative and science-driven working environment.