job description
Aromate Philippines Co. Inc is seeking a dedicated Regulatory Compliance Pharmacist to join our team in Bali. In this role, you will ensure that our manufacturing processes comply with FDA and GMP standards, manage regulatory submissions, and support production activities. You will also play a key role in assisting with audits and maintaining our commitment to quality and compliance.
This is an excellent opportunity for a detail-oriented pharmacist with a passion for regulatory affairs to contribute to a leading company in the healthcare industry. If you are looking for a challenging and rewarding career in a dynamic environment, we encourage you to apply.
Responsibility
- Ensure compliance with FDA and GMP regulations in manufacturing processes.
- Manage and prepare regulatory submissions and documentation.
- Support production activities to maintain compliance with regulatory standards.
- Assist in internal and external audits to ensure adherence to regulations.
- Collaborate with cross-functional teams to implement compliance initiatives.
- Monitor and report on regulatory changes that may impact operations.
- Provide training and guidance to staff on compliance-related matters.
- Maintain accurate records and documentation for regulatory purposes.
Qualifications
- Bachelor's degree in Pharmacy or a related field.
- Valid pharmacist license.
- Minimum of 2 years of experience in regulatory compliance or a related role.
- Strong knowledge of FDA and GMP regulations.
- Excellent attention to detail and organizational skills.
- Ability to work independently and as part of a team.
- Strong communication and interpersonal skills.
- Proficiency in Microsoft Office and regulatory software.