American Taiwan Biopharm Co., Ltd. (ATB): is a joint venture between TTY Biopharm Co., Ltd. (Taiwan) and a group of American investors. With over 25 years of experience in pharmaceutical industry, ATB has recently emerged as one of the leading marketing-driven pharmaceutical companies in Southeast Asia (SEAs), by offering all stakeholders high-quality & affordable pharmaceutical products, aiming to improve peoples quality of life & accessibility across the region.
Key Responsibilities
- Prepare, submit and follow up by-priority ANDA & NDA submissions and develop regulatory strategy to secure the approvals in timely manner.
- Manage post-approval activities, including license maintenance, renewals, GMP clearance, change of control processes, and pharmacovigilance support.
- Review and prepare packaging artwork, label & PIL per approval.
- Arrange regulatory documents in tidy manner for audit and legal reference.
- Update regulatory regulations and evaluate the impacts on business.
- Develop strategic relationships with authorities to ensure smooth approvals.
- Liaise with local RA agencies in SEAs to accelerate the approvals.
- Lead, coach and support RA associates on regular basis.
- Coordinate & support commercial, business development & supply chain teams, from regulatory perspective, such as tenders, advertising approvals, in-licensing projects, importation, etc.
Qualifications
- Bachelor of Pharmacy & minimum 7 years of RA experience both ANDA & NDA.
- Analytical & problem-solving abilities, aligned with SEAs regulatory frameworks.
- Result-oriented & business-driven mindsets with leadership.
- Good interpersonal skills & ability to collaborate across functions in the organization.
- Excellent proficiency in English together with communication skills.
The company offers competitive remuneration packages for the right candidate. Only the right candidate will be informed for the final interview. Your CV shall be strictly kept confidential. If youre ready to explore this challenging opportunity, please share your CV to [Confidential Information] Tel. +66 2272 0630-4.
