RA associate (2 years)

[Job Description]

- Mainly responsible for checking and ensuring regulatory compliance of registered pharma portfolio (drug products, active substances / DMFs and medical device) by reviewing global registration dossier and local registrations for the products and substances

- Manage planning and execution of regulatory activities related to the review and check of regulatory compliance of registered products in compliance with global standards and local regulations

- Ensures regulatory compliance for a sustainable life-cycle management when assigned: manage labeling and CMC changes in accordance with local regulations and relevant global SOPs

- Provide regulatory gap analysis and risk mitigation plan, timely communicate to local & regional RA management in relation to regulatory compliance checking.

- Review and approve packaging texts to ensure compliance with registration and legal requirements.

- Maintain global regulatory databases accordingly, and archive registration dossier of assigned portfolio in accordance with global and local SOP.

- Monitor and timely communicate upcoming regulation or policy changes for assigned area including preliminary impact analysis.

[Qualifications / Requirement]

- Life Sciences based BS or MS with requisite experience and demonstrated track record.

- Preferably more than 3 years’ experience in regulatory or drug/biologic development experience in pharmaceutical industry.

- Good in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills. Good cross-functional communication skills

- Knowledge of local regulatory framework, compliance aspects related to regulatory affairs function and other relevant country requirements applicable to pharmaceuticals and medical devices is desired.

[근무조건]

근무 형태: 계약직

근무 요일/시간: 주 5일(월~금)

근무 지역: 서울 영등포구 여의도동

급여: 회사내규에 따름

[문의사항]

전화: 02 - 829 - 6511
E-mail: yeonsoo.kim@bayer.com

[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.)