Deskripsi Pekerjaan
Are you a strategic thinker with a passion for compliance and quality assurance? Our client, a leading FMCG company in Indonesia, is seeking a dedicated Regulatory Affairs Manager to join their dynamic team. Renowned for high-quality products and a strong commitment to customer satisfaction, our client offers a unique opportunity to shape the regulatory landscape of the industry.
In this pivotal role, you will oversee the regulatory strategies for new product launches and ensure full compliance with local and international standards. You will act as the primary liaison with regulatory bodies, managing the submission and approval processes for all products. This is a chance to lead a team, influence product development, and ensure that consumer safety remains the company's top priority.
If you are looking for a challenging and rewarding career in a fast-paced environment, we encourage you to apply today.
Tanggung Jawab
- Develop and implement comprehensive regulatory strategies for new product launches in the Indonesian market.
- Manage interactions with regulatory authorities, including BPOM and relevant government agencies.
- Prepare and submit accurate dossiers and technical documentation for product registrations and renewals.
- Monitor changes in local and international legislation to ensure continuous compliance.
- Coordinate closely with R&D, Quality Assurance, and Marketing teams to align product development with regulatory requirements.
- Conduct internal audits and risk assessments to identify potential compliance gaps.
- Represent the company at industry forums and regulatory meetings as needed.
Kualifikasi
- Bachelor’s degree in Pharmacy, Biology, Chemistry, Law, or a related scientific field.
- Minimum of 5-7 years of experience in Regulatory Affairs within the FMCG sector.
- Deep understanding of Indonesian pharmaceutical, food, or cosmetic regulations (BPOM).
- Strong knowledge of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice) guidelines.
- Excellent communication, negotiation, and interpersonal skills.
- Detail-oriented with strong problem-solving and organizational abilities.
- Proficiency in MS Office and regulatory database management systems.