job description
Join Sprint Asia Logistics Inc. as a Regulatory Pharmacist and play a pivotal role in ensuring compliance with FDA regulations for pharmaceutical and healthcare products in a dynamic, fast-paced environment. Based in the vibrant region of Badung, Bali, you will oversee the end-to-end process of product registration, documentation, and regulatory submissions, ensuring seamless market access while adhering to local and international standards.
This is a unique opportunity for a detail-oriented Registered Pharmacist to leverage their expertise in regulatory affairs, compliance, and supplier coordination. You will collaborate with cross-functional teams, including legal, quality assurance, and supply chain, to maintain the highest standards of regulatory adherence. Your work will directly impact the company’s ability to deliver safe, compliant, and high-quality healthcare solutions to the market.
If you are passionate about pharmaceutical regulations, documentation accuracy, and strategic problem-solving, this role offers a rewarding career path with opportunities for professional growth in the thriving healthcare and logistics industry.
Responsibility
- Manage and oversee the FDA product registration process, including initial submissions, amendments, and renewals for pharmaceutical and healthcare products.
- Ensure 100% compliance with local and international regulatory requirements, including labeling, packaging, and documentation standards.
- Coordinate with suppliers, manufacturers, and distributors to gather necessary documentation and certifications for regulatory submissions.
- Develop, review, and maintain regulatory dossiers, technical files, and submission packages in accordance with FDA guidelines.
- Monitor and track regulatory changes and updates to ensure timely adjustments to company policies and procedures.
- Conduct internal audits and compliance checks to identify gaps and implement corrective actions.
- Liaise with FDA officials and regulatory bodies to address inquiries, resolve issues, and facilitate approvals.
- Provide training and guidance to internal teams on regulatory requirements and best practices.
Qualifications
- Bachelor’s Degree in Pharmacy with a valid Pharmacist License (mandatory).
- Minimum 3 years of experience in regulatory affairs, FDA compliance, or product registration within the pharmaceutical or healthcare industry.
- In-depth knowledge of FDA regulations, ICH guidelines, and GMP standards.
- Proven experience in preparing and submitting regulatory dossiers, technical files, and compliance documentation.
- Strong analytical, organizational, and problem-solving skills with meticulous attention to detail.
- Excellent written and verbal communication skills in English for stakeholder coordination.
- Proficiency in Microsoft Office Suite and regulatory management software.
- Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.