Sr. Regulatory Affairs Specialist
1개월전에
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
[ROLE SUMMARY]
Sr. Regulatory Affairs Specialist 는 Regulatory Affairs Director, Korea 에 보고하며, 신규 제품의 한국허가를 위해 전략을 마련하고, 신청자료를 준비해 식약처와 협의합니다. 기허가 제품들이 최신 허가 규정에 맞게 관리될 수 있도록 허가 변경, 갱신, 사후 관리를 진행합니다.
Medical, Supply Chain, Quality 등의 유관 부서와 협업하며, 전문 지식과 전략적 사고를 바탕으로 제품 주기 전반에 걸쳐 인허가 및 의약품 관련 규정에 대한 인사이트를 제공합니다.
Prepare filing & obtain marketing approval from MFDS for the new drug and planned variations to ensure maintenance of registered drugs
Provide regulatory insight & strategies to cross function team as regulatory liaison throughout the product lifecycle
Maintain country labeling documents & related works (such as labeling, artwork review/approval, relevant internal system and database updates)
[RESPONSIBILITIES]
File and obtain marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered and coordinate K-IND filing.
Updates the assigned country labeling information in consistent with the local regulations and Core Data Sheet update and manage updates the related databases.
Provides regulatory affairs related information to other divisions/departments and coordinate regulatory activities between cross-functions.
Review Promotional material as regulatory viewpoint.
Aware the external regulatory environment, including competitor intelligence and regulatory actions, in order to provide informed input to regulatory strategies.
Establishes, develops and maintains close working relationships with the relevant regulatory authorities and associations.
Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
[QUALIFICATIONS]
Major: Bachelor degree in Pharmacy
Work experience: Prefer 4-5 year experience in Regulatory affairs in Pharmaceutical industry
Other: Agile to change, Decision making, Negotiation skill, Leadership, Project management skill, Teamwork, Computer skills, Fluency in written & spoken English and Korean
APPLICATION DEADLINE : 2024-04-15 (MON)
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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