[Tasks and Responsibilities (담당 업무 및 책임)]

-Obtain and defend regulatory approvals of new biotech products from Korean regulatory agencies to secure global commercialization

-Monitoring and timely communicating policy change and regulatory requirement change, and lead timely regulatory strategy development and execution;

-Lead product specific data generation and submission strategy development/execution to ensure product deliverables.

-Work internally with Regional and Global Seed & Traits Regulatory Science teams to gain strategy alignment for regulatory submissions.

-Prepare high quality dossiers, and guide right regulatory data positioning to enable timely product approval.

-Interact with regulatory agencies to explain the submitted dossier and respond to the technical questions.

-Develop a strategy on the response to the questions and lead internal alignment on critical questions with colleagues in Global.

-Develop and provide input on study protocols for both internal and government required regulatory studies to ensure science-based, well-compliance study design in order to ensure timely approvals.

-Solve cross-cutting issues by closely working with both internal and external stakeholders

-Defend our data and promote science base requirements for product approvals.

-Maintain regulatory approvals for approved traits in Korea to ensure smooth Ag trade for Bayer products;

-Engage in “License to operate” activity to develop science based and predictable regulatory policy and environment: developing/reviewing talking points for government and scientific outreaches, scientific communication with regulators, influence and lead regulatory discussions among industry by closely working with both internal and external stakeholders.

 

[Qualifications/Requirement (자격/조건)]

-Education: BS, MS or Ph.D in Science preferred biochemistry, molecular biology, plant biology, protein chemistry, agronomy, plant breeding, chemistry or related discipline. 

-Experience: Minimum of 3 years of regulatory affairs or relevant experiences in agricultural, biotechnology, crop protection, pharmaceutical or related scientific based industry. 

-Excellent written and oral language skill in both local language and English to convey complex ideas in a clear, precise, and logical manner.

-Strong technical background to understand the regulatory data and good understanding on political and/or regulatory environment;

-Strong skill on science communication, negotiation and influencing

-Excellent results orientation and attention to details.

-Highly developed planning and time management skill, persistence to overcome regulatory challenges and move forward with a submission project as scheduled.

-Good cooperative personality for team work and good communication skill to communicate with both internal and external stakeholders.

 

[근무조건]

근무 형태: 정규직

근무 요일/시간: 주 5일(월~금)

근무 지역: 서울특별시 영등포구 여의대로 108, 타워2 (파크원)

급여: 회사내규에 따름

 

[기타 안내사항]

- 면접은 서류전형 합격자에 한해 개별통지 합니다.

- 국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대합니다.

- 남자는 병역필 또는 면제자로 해외출장에 결격사유가 없는 자를 모집합니다.

- 제출하신 서류는 일체 반환하지 않습니다.

- 입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

- 신체적 조건과 출신 지역, 혼인 여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직업, 재산과 관련된 정보는 지원서류에 포함하지 마십시오. 

(단, 바이엘코리아에 재직 중인 가족이 있을 경우, 회사가 공정한 채용을 위한 조치를 취할 수 있도록 입사지원서를 통해 사전에 고지해 주시기 바랍니다)