 Support the global regulatory lead in the implementation and development of innovative regulatory strategies for assigned projects with the objectives of successful development and timely registration.
 Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
 Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
 Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions
 Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
 Works with international regulatory representatives for strategic planning and preparation of Regulatory Strategies.
 Provides regulatory impact assessments and approves change controls as required.
 Identify and communicate potential risks associated with strategy scenarios.
 Review and approve manufacturing production processes, test methods and validations as required.
 Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
 Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
 Performs all other related duties as directed by supervisor and management.
 Responsible for the company’s drug surveillance program including the necessary follow-up, assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
 Participate in the resolution of any liability and complying with governmental regulations.
 May provide trending and safety signal detection and risk management assessment for the product’s life cycle.

 Pharmacist license required
 Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy)
 Less than 2 years of experience with the pharmaceuticals and/or other related field
 Must be detail oriented, proactive and adaptable
 Good initiative and self-motivated
 Ability to work under tight deadlines/pressures
 Good communication and interpersonal skills
 Proficiency in English (Preferred)

- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자