job description
Join Cekindo Business International as a Regulatory Affairs Team Leader and take the helm of our regulatory compliance and product registration initiatives in Bali. This is a unique opportunity to lead a dynamic team, ensuring seamless adherence to local and international regulations across diverse industries, including healthcare, pharmaceuticals, and consumer goods.
In this pivotal role, you will collaborate with cross-functional teams, government agencies, and industry stakeholders to navigate complex regulatory landscapes. Your expertise will drive strategic decision-making, ensuring our clients' products meet all legal and safety standards while accelerating time-to-market.
Based in the vibrant and culturally rich island of Bali, this position offers a blend of professional growth and an unparalleled work-life balance. If you are a seasoned regulatory affairs professional with a passion for leadership and compliance, we invite you to apply and make a significant impact in a thriving, innovative environment.
Responsibility
- Lead and manage the Regulatory Affairs team, ensuring timely and accurate submission of product registrations and compliance documentation.
- Develop and implement regulatory strategies to support business objectives and ensure adherence to local and international regulations.
- Act as the primary liaison with government agencies, industry bodies, and internal stakeholders to facilitate smooth regulatory processes.
- Review and approve regulatory submissions, ensuring all documentation meets required standards and guidelines.
- Monitor and interpret changes in regulatory policies, providing strategic recommendations to senior management.
- Conduct risk assessments and mitigate potential regulatory issues that could impact product launches or business operations.
- Train and mentor team members, fostering a culture of continuous learning and professional development.
- Collaborate with R&D, legal, and marketing teams to ensure regulatory compliance throughout the product lifecycle.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Law, or a related field. Advanced degree preferred.
- Minimum of 7 years of experience in regulatory affairs, with at least 3 years in a leadership role.
- In-depth knowledge of Indonesian regulatory frameworks, including BPOM, MOH, and other relevant agencies.
- Proven track record of successfully managing product registrations and compliance projects.
- Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements.
- Excellent communication and negotiation skills, with fluency in English and Bahasa Indonesia.
- Ability to work in a fast-paced environment, managing multiple priorities and deadlines.
- Professional certification in regulatory affairs (e.g., RAC) is a plus.