job description
Join Drugmaker's Laboratories, Inc as a Regulatory Officer and play a pivotal role in ensuring our pharmaceutical products meet the highest regulatory standards. Based in the vibrant regions of Bali, you will manage submissions, compliance, and documentation to uphold our commitment to quality and safety.
This role offers a unique opportunity to work in a dynamic environment, collaborating with cross-functional teams to navigate regulatory landscapes and drive operational excellence. If you are detail-oriented, analytical, and passionate about regulatory affairs, we invite you to apply and contribute to our mission of delivering safe and effective pharmaceutical solutions.
Responsibility
- Manage and prepare regulatory submissions to local and international authorities.
- Ensure compliance with pharmaceutical regulations and standards.
- Maintain and update regulatory documentation and records.
- Coordinate with internal teams to gather necessary data for submissions.
- Monitor regulatory changes and update internal policies accordingly.
- Conduct audits and inspections to ensure adherence to regulatory requirements.
- Provide regulatory guidance and support to cross-functional teams.
- Liaise with regulatory agencies and respond to inquiries or requests for information.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
- Strong knowledge of local and international pharmaceutical regulations.
- Excellent written and verbal communication skills.
- Detail-oriented with strong organizational and analytical skills.
- Ability to work independently and as part of a team.
- Proficiency in regulatory software and documentation tools.
- Familiarity with GMP, GCP, and other relevant standards.