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 Affair Specialist 는 비아트리스 코리아의 신약 및 기허가 제품의 변경 사항에 대한 인허가 자료를 작성하고, 식약처와 협의합니다. 기허가된 제품을 안정적으로 유지/관리하며, 규제 및 허가와 관련된 전문 지식과 전략적 사고를 바탕으로 제품의 전체 수명 주기 동안 주요 이해당사자들과 긴밀하게 협업하며, 규제 관련 인사이트와 전략을 제공하는 역할이 기대됩니다. 더불어 비아트리스 코리아의 라벨링 업무(라벨링, 제품 설명서/포장재 등의 검토, 내부 시스템 및 DB 업데이트)도 함께 수행하게 됩니다.

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).

[ROLE 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, especially Prefer RA experience to manage post approval change related with the quality and GMP.

Other: Agile to change, Decision making, Negotiation skill, Leadership, Project management skill, Teamwork, Computer skills, Fluency in written & spoken English and Korean

APPLICATION DEADLINE: 2025-02-20 (THU)

* 후보자의 경력 및 역량 수준에 따라 최종 직급 및 Position Title 은 변경될 수 있습니다.

At Viatris, we offer competitive salaries, benefits and an 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.