job description
Join Health Wellness Lifestyle, Inc. as a Regulatory Pharmacist and play a pivotal role in ensuring our organization adheres to FDA regulations, licensing requirements, and compliance standards in the dynamic healthcare industry. Based in the vibrant hub of Bali, Indonesia, this position offers a unique opportunity to contribute to public health while working in a tropical, inspiring environment.
As a Regulatory Pharmacist, you will be the backbone of our compliance framework, managing critical documentation, registrations, and government submissions to maintain seamless operations. Your expertise will directly impact our ability to deliver safe, high-quality healthcare products and services while mitigating legal and operational risks.
This role is ideal for detail-oriented professionals with a passion for pharmaceutical regulations, quality assurance, and regulatory affairs. If you thrive in a structured yet innovative environment and want to make a tangible difference in healthcare compliance, we invite you to apply.
Responsibility
- Oversee and manage all FDA and regulatory submissions, ensuring timely and accurate filing of licenses, permits, and registrations.
- Develop, review, and maintain compliance documentation, including SOPs, policies, and audit reports.
- Monitor and interpret changing regulatory requirements to ensure the company remains up-to-date with local and international standards.
- Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Quality Assurance) to align processes with regulatory expectations.
- Conduct internal audits and risk assessments to identify and mitigate compliance gaps.
- Serve as the primary liaison with government agencies, FDA representatives, and external auditors.
- Provide training and guidance to staff on regulatory best practices and compliance protocols.
- Prepare and submit annual reports, product registrations, and post-market surveillance documentation.
Qualifications
- Bachelor’s degree in Pharmacy (or equivalent) with a valid Pharmacist license.
- Minimum 3-5 years of experience in regulatory affairs, compliance, or a related field within the pharmaceutical/healthcare industry.
- In-depth knowledge of FDA regulations, GMP, and local pharmaceutical laws.
- Proven experience in documentation management, licensing, and government submissions.
- Strong analytical, problem-solving, and organizational skills with meticulous attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work independently and manage multiple deadlines in a fast-paced environment.
- Familiarity with regulatory software and compliance tools is a plus.