job description
Join Ambica International Corporation as a Regulatory Affairs Pharmacist in beautiful Bali! Enjoy a day shift schedule with fixed weekends off, allowing you to maintain a healthy work-life balance while advancing your career in the pharmaceutical industry.
This role offers quarterly performance-based incentives, competitive compensation, and the opportunity to work with a dynamic team in a fast-paced, compliance-driven environment. As a Regulatory Affairs Pharmacist, you will play a pivotal role in ensuring our products meet all local and international regulatory standards, facilitating smooth market access and compliance.
If you are a detail-oriented pharmacist with a passion for regulatory affairs and a desire to work in a tropical paradise, this is your chance to make a meaningful impact while enjoying the vibrant culture and lifestyle of Bali.
Responsibility
- Prepare, review, and submit regulatory documentation to local and international health authorities (e.g., BPOM, FDA, EMA).
- Ensure compliance with pharmaceutical laws, guidelines, and company policies for product registration, licensing, and post-market surveillance.
- Collaborate with cross-functional teams (R&D, Quality Assurance, Manufacturing) to gather and compile technical data for regulatory submissions.
- Monitor and interpret changes in regulatory requirements, advising the organization on necessary adjustments to maintain compliance.
- Coordinate and manage product registrations, renewals, and variations, ensuring timely approvals and market access.
- Conduct gap analyses and risk assessments for regulatory submissions to mitigate potential compliance issues.
- Represent the company in meetings with regulatory agencies, addressing inquiries and providing clarifications as needed.
- Maintain and update regulatory databases, ensuring accurate and up-to-date records of submissions, approvals, and correspondence.
Qualifications
- Bachelor’s degree in Pharmacy (S.Farm) or equivalent; a Master’s degree in Regulatory Affairs or related field is a plus.
- Minimum of 3 years of experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry.
- In-depth knowledge of Indonesian (BPOM) and international regulatory requirements (e.g., ICH, ASEAN, FDA, EMA).
- Proven experience in preparing and submitting dossiers, CTDs, and other regulatory documents for drug registration.
- Strong analytical, organizational, and project management skills with the ability to meet tight deadlines.
- Excellent written and verbal communication skills in English and Indonesian.
- Proficiency in regulatory software/tools (e.g., Veeva, TrackWise) is highly desirable.
- Attention to detail, problem-solving mindset, and ability to work independently or in a team.