Regulatory Affairs Specialist

PT Tentang Anak Bahagia; Daerah Khusus Ibukota Jakarta; On-site; IDR 111,600,000 - 167,400,000; Full time

Job summary

A children's education company in Jakarta is seeking a Regulatory Affairs Specialist to ensure compliance with regulatory requirements for product licenses. The ideal candidate will have at least 3 years of experience in regulatory affairs, strong analytical skills, and the ability to work in a cross-functional team. This position offers an opportunity to contribute to the success of a company dedicated to children's well-being.

Qualifications

• Minimum of 3 years of experience in regulatory affairs.
• Strong understanding of regulatory requirements and procedures.
• Ability to work in a cross-functional team.

Responsibilities

• Prepare and manage regulatory documents for product approvals.
• Liaise with regulatory agencies for approval processes.
• Develop regulatory strategies for new products.
• Collaborate with teams to meet regulatory standards.

Skills

Regulatory knowledge

Analytical skills

Interpersonal skills

Detail-oriented

Problem-solving

Communication skills

Education

Bachelor's degree in a relevant field

Job description

About the job Regulatory Affairs Specialist

About Tentang Anak

Imagine a career where you play a pivotal role in ensuring the success and bright future of 80 million children in Indonesia. Tentang Anak is not just a company; it's a mission, a movement, and an opportunity to be part of something truly extraordinary.

Tentang Anak, at its core, is driven by a mission to advance the well-being and development of 80 million children throughout Indonesia. Founded by a team of experts, including pediatricians, child psychologists, and early childhood educators, we are steadfast in our commitment to supporting children with the most reliable education and products. From educational tools (e.g., applications, books, flashcards, puzzles) to essential skincare, Tentang Anak aims to accompany and provide the best solutions for parents and their children, from the moment they wake up until they fall asleep.

Our products are the one and only in Indonesia that are developed by experts, backed by science, and offered at affordable prices. We are humbled by the love our products receive from parents, consistently ranking our Educational Tools and Skincare highly on e-commerce platforms, making them best-sellers. We will continue to innovate and provide better solutions for parents at every step of their journey. We are dedicated to creating a brighter, healthier, and happier future for the children of Indonesia.

Our employees, whom we call TAmily, are a group of relentless and passionate individuals who share the same mission and ambitions. Are you ready to join us in this mission?

About The Role

The Regulatory Affairs Specialist will play a critical role in ensuring compliance with regulatory requirements and contributing to the success of our products in the market. The successful candidate will be responsible for managing the registration process and obtaining/maintaining government approvals for Tentang Anak product licenses (BPOM/Halal/SNI/ISBN).

Job Description

• Regulatory Submissions: Prepare, submit, and manage regulatory documents and applications for product registrations, approvals, and renewals.
• Liaise with regulatory agencies to facilitate the approval process and address any inquiries or requests for additional information.
• Develop and execute regulatory strategies to facilitate the 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 that products meet regulatory standards and requirements.
• Communicate regulatory information to internal teams and external partners, ensuring awareness and understanding of regulatory requirements.

Requirements

• Bachelor's degree in a relevant field, communication, government studies, management.
• Proven working experience of at least 3 years in regulatory affairs within the pharmaceutical, FMCG industry, and nutritional products industry.
• In-depth knowledge of regulatory requirements and procedures.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with a focus on accuracy and compliance.
• Familiarity with regulatory agencies and the submission process.