402 Regulatory Affairs jobs in Indonesia

Here's a snapshot of what we're looking for:

• Minimum 3 years of proven experience in regulatory affairs
• Strong expertise in managing BPOM registration
• Hands-on experience handling CPPOB certification
• Proven track record in Halal certification process
• Familiar with regulatory guidelines and documentation requirements
• Excellent coordination with government authorities and stakeholders
• Detail-oriented, reliable, and proactive in providing regulatory solutions

Work Location: Gold Coast Office, PIK 1

Working Hours: Monday to Friday, 09:00 – 18:00 WIB

• Ensure compliance with all relevant national and international regulations.
• Prepare and submit regulatory documentation for product approvals and registrations.
• Liaise with regulatory authorities and respond to inquiries.
• Stay updated on changes in regulatory requirements and guidelines.
• Develop and implement regulatory strategies.
• Conduct internal audits and support external regulatory inspections.
• Collaborate with cross-functional teams on regulatory matters.
• Advise on regulatory implications of product development and changes.

• Bachelor's or Master's degree in a science-related field (e.g., Pharmacy, Chemistry, Biology, Engineering).
• Minimum of 5 years of experience in regulatory affairs within a regulated industry.
• In-depth knowledge of relevant regulatory frameworks and submission processes.
• Proven ability to prepare and manage regulatory submissions.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills in English.
• Ability to work independently and manage priorities effectively in a remote setting.

Job Responsibilities – Regulatory Officer & Person in Charge (PJT):

1. Manage product registration and licensing processes.
2. Ensure compliance with applicable regulations.
3. Act as coordinator and self-assessment controller/checker for CDAKB & CDOB certification.
4. Register and renew product licenses (NIE/AKL).
5. Collaborate with Business Development, Product, Marketing, and Import divisions to manage product licensing and regulatory matters.
6. Access and manage all accounts related to the Ministry of Health (Kemenkes), BPOM, OSS, and other regulatory platforms.
7. As PJT, ensure product quality, compliant distribution, and the company's technical regulatory compliance.
8. Prepare E-Suket for non-medical devices when required.
9. Prepare and submit e-reports for the distribution of medical devices and pharmaceuticals.
10. Handle SIMODIS reporting.

Qualifications:

1. Bachelor's degree in Pharmacy, Chemistry, Biology, Public Health, or other related fields.
2. Minimum 1–2 years of experience in regulatory affairs, product registration, or related fields in the medical device/pharmaceutical industry.
3. Familiar with CDAKB, CDOB, BPOM, OSS, and Ministry of Health (Kemenkes) regulations.
4. Registered Pharmacist or eligible to be appointed as PJT (Technical Responsible Person for Medical Devices) is a strong advantage.
5. Strong knowledge of product licensing, compliance, and regulatory processes.
6. Excellent communication and coordination skills across departments (Business Development, Marketing, Import, Product).
7. Detail-oriented, organized, and able to manage multiple regulatory accounts and reporting systems (e.g., Simodis, e-reporting).
8. Proficient in Microsoft Office and regulatory platforms (Kemenkes, BPOM, OSS).
9. Good command of English, both written and spoken is a plus

Job Description :

Regulatory Submissions & Compliance

• Prepare, coordinate, and manage regulatory submissions (e.g., INDs, Initial/Renewal/Variation Registration, CTILs, SAS, PSUR, Routine Activity Reports) in accordance with applicable regulations.
• Translate regulatory requirements into practical, workable submission plans and maintain timelines.
• Actively follow up with Regulatory Authorities and the Ministry of Health regarding submissions and approvals.

Regulatory Liaison & Relationship Management

• Liaise with Regulatory Authorities and the Ministry of Health to support the development of new regulations.
• Manage relationships with registration consultants and distributors to ensure timely and accurate delivery of services as per agreements.
• Build and maintain effective working relationships with regulatory authorities, consultants, and distributors.

Regulatory Support & Business Partnership

• Provide accurate and constructive feedback to Business Development during document review for new products.
• Review and communicate current and emerging regulatory requirements with related departments (Business Development, Medical, Marketing).
• Provide regulatory support for Clinical Development activities, including review of quality documents.
• Monitor industry and regulatory developments, advising senior management on potential business impacts.

Job Requirement :

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or related field.
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
• Proven track record in regulatory submissions, product registrations, and interactions with regulatory authorities (e.g., BPOM, Ministry of Health).
• Strong knowledge of local and international regulatory requirements, guidelines, and industry standards.
• Excellent communication and negotiation skills, both written and verbal, in English and Bahasa Indonesia.
• Strong analytical and problem-solving abilities with attention to detail.
• Ability to build effective relationships with internal stakeholders and external regulatory bodies.
• Project management skills with the ability to manage multiple priorities and timelines.

• Assist in preparing and compiling documents for product registration submissions.
• Support preparation of PIF or DIP (Dokumen Informasi Produk) in line with regulatory requirements.
• Conduct desk research on regulations, guidelines, and requirements relevant to the industry.
• Provide administrative support, including organizing files, data entry, and maintaining regulatory databases

Requirement

• Final-year student or fresh graduate from Pharmacy, Chemistry, Biology, Food Technology or Industrial Engineering.
• Strong attention to detail.
• Basic knowledge or interest in regulatory affairs, product compliance, or supply chain management is an advantage.

• Proficient in Microsoft Office (Word, Excel, PowerPoint).

• Avail for 3 months paid internship

Responsibilities:

• Prepare registration documents, submit product registrations, and manage regulatory documents and applications for product registrations, approvals, and renewals.
• Liaise with regulatory agencies to facilitate the approval process and address inquiries or requests for additional information.
• Develop and execute regulatory strategies to ensure timely approval and launch of new products.
• Provide input into product development strategies based on regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to ensure products meet regulatory standards and requirements.
• Communicate regulatory information to internal teams and external partners to ensure awareness and understanding of regulatory requirements

Requirements:

• Minimum 2 years of Regulatory Affairs experience in the beauty and/or personal care industry
• Bachelor's degree in Pharmaceutical Sciences or Apothecary
• Apothecary Certified is mandatory (possessing a valid STRA/ Surat Tanda Registrasi Apoteker certificate)
• In-depth knowledge of regulatory requirements and procedures
• Familiarity with regulatory agencies and the submission process
• Fluency in English, both oral and written, is essential
• Willingness to work under the WFO (Work from Office) policy

JOB REQUIREMENT

• Pendidikan min. D3
• WAJIB berpengalaman min. 2 thn
• Memahami alur proses perizinan bisnis
• Memahami proses CDAKB, NIE, E-Report, INAPROC, TKDN, KFA & OSS
• Memahami alur perizinan alat kesehatan
• Mahir menggunakan Ms. Office (excel, power point dan ms. Word)

JOBDESK :

• Bertanggung jawab atas pembuatan perizinan baru & perpanjangan : CDAKB, NIE, E-Report, INAPROC, TKDN, KFA & OSS
• Berkomunikasi dengan pihak Kemenkes
• Membantu marketing untuk proses E-catalogue
• Membuat dokumen tambahan yang diperlukan oleh perusahaan yang berkaitan dengan izin edar perusahaan
• Bertanggung jawab terhadap E-report Kemenkes
• Bertanggung jawab terhadap sistem E-catalogue perusahaan
• Membuat data LKPM
• Melaporkan KFA Produk perusahaan ke kemenkes

Deskripsi Pekerjaan

• Bertanggung jawab atas perizinan & perpanjangan ( CDAKB, KFA, TKDN, OSS, E-Report)
• Menyiapkan dokumen-dokumen registrasi import
• Memperbaharuai E-Catalogue dan E-Report
• Memeriksa laporan-laporan produk

Kualifikasi :

1. Pendidikan min DII relevan

2. Memiliki Pengalaman sebagai Regulatory Affairs

3. Memahami alur proses perizinan ( CDAKB, OSS, KFA, TKDN, E-Report)

4. Memahami regulasi BPOM, Kementerian Perdagangan, Kemeterian kesehatan, dan instasi terkait.

5. Mampu menguasi Ms.Pack (Word, Excel, dan Power point )

6. Kemampuan Analisis yang kuat, dan komunikatif

About the Job:
Assisting
Health-Hygiene
product registration, and its compliance, support work of local regulatory function and sustainability in cooperation with Reckitt cross-functional team (supply, quality, commercial) and global/regional function.

Scope:
Support regulatory compliance activities of Health-Hygiene product prior to marketed:

• Compiles information and filings pertaining to regulatory and product registration requirement, product labelling and advertisement requirement, and ensure for its compliance
• Assists in product registration submission, registration renewal and related process to obtain authority approval in timely manner.
• Communicate with authorities, RAS colleague and cross function for registration requirement and regulatory advice.
• Monitoring and keep update regulation and regulatory requirements pertaining to Health-Hygiene Product.
• Assist sustainability project, communication with sustainability teams and external stakeholders.

In summary, you'll:

• Timely preparation and compilation dossier/registration documents (new product registration, variation, and renewal), and advertisement submission.
• Review registration documents prior to submission and ensure its compliance according to authority requirement.
• Review product labelling to ensure it meets Regulatory requirement.
• Maintaining record of regulatory document dossiers and related consultation, registration approval (includes label), and copy of label and advertising approvals its communication to filing system in accordance with record retention policy.
• Maintaining regulatory/policy system
• Communicate and establishing/maintaining good relationship with authorities.
• Support Reckitt sustainability project, prepare and compile report to Ministry of Environment, monitoring and update sustainability regulation, and communication with external stakeholders.

The experience we're looking for:

• Must have a degree in Chemistry, Chemical Engineering, Biology, Pharmacist, Food Science
• Minimum experience 1 year in regulatory affairs field is preferred.
• Language skills: Fluent in English and Bahasa Indonesia.
• Organizational skills: managing documentation and deadlines.
• Analytical thinking: to interpret regulatory guideline and asses regulatory and product compliance.
• Having a sense of urgency, self-driven, efficient when accomplishing the job.
• Proactive self- starter. Able to keep manager informed of progress as appropriate.
• Strong communication, influencing and interpersonal skills.
• Commitment and can-do attitude.
• Proficiency in tools like Microsoft Excel, Word, and regulatory databases/system.
• Possess Reckitt – Values – Achievement, team-spirit, Entrepreneurship, Ownership and Responsibility.

What We Offer
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.

We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.