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.
경력 및 자격요건
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)
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
