job description
Join C'SCOR, a leading innovator in healthcare and medical product development, as our Regulatory Affairs Officer (Formulator - FDA & IPO Compliance) in the vibrant heart of Bali, Indonesia. This is a unique opportunity to play a pivotal role in ensuring our products meet stringent regulatory standards while contributing to groundbreaking advancements in the industry.
As a key member of our regulatory team, you will bridge the gap between product formulation and compliance, working closely with R&D, quality assurance, and legal teams to navigate the complex landscape of FDA and IPO regulations. Your expertise in product formulation, testing, and regulatory affairs will be instrumental in driving our mission to deliver safe, effective, and compliant healthcare solutions to global markets.
Bali offers an unparalleled work-life balance, with its stunning landscapes, rich culture, and thriving expat community. At C'SCOR, we foster a collaborative and dynamic work environment where innovation and professional growth are encouraged. If you are passionate about regulatory affairs, product formulation, and making a tangible impact in the healthcare sector, we invite you to be part of our team.
This full-time role is based in Badung, Bali, with hybrid work options available. We offer a competitive salary package, comprehensive benefits, and opportunities for career advancement in a globally recognized organization.
Responsibility
- Lead the regulatory submission process for new and existing products, ensuring compliance with FDA, IPO, and other relevant regulatory bodies.
- Collaborate with R&D and formulation teams to develop and refine product formulations that meet regulatory standards and market requirements.
- Prepare, review, and submit regulatory documentation, including dossiers, technical files, and compliance reports.
- Monitor and interpret changes in regulatory guidelines and update internal processes and documentation accordingly.
- Conduct risk assessments and gap analyses to identify potential regulatory issues and propose mitigation strategies.
- Act as the primary liaison with regulatory authorities, addressing queries and facilitating inspections or audits.
- Provide regulatory guidance and training to cross-functional teams to ensure alignment with compliance requirements.
- Maintain accurate records of all regulatory activities and ensure timely renewals of product registrations and certifications.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or a related field. Advanced degree or certification in Regulatory Affairs is a plus.
- Minimum of 3-5 years of experience in regulatory affairs, product formulation, or R&D within the healthcare, pharmaceutical, or medical device industry.
- Proven experience with FDA and IPO regulatory submissions and compliance processes.
- Strong understanding of product formulation, testing methodologies, and quality control standards.
- Excellent analytical, organizational, and project management skills with keen attention to detail.
- Proficiency in regulatory software and tools, as well as Microsoft Office Suite.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluency in English; additional languages are a plus.