Regulatory Affairs Associate (2 years contract)


Your tasks and responsibilities

- Manage planning and execution of regulatory affairs activities (e.g. preparation and submission of new registration, line extension, post-approval variations) and follow through from submission to approval. 
- Provide regulatory gap analysis and risk mitigation plan, timely communicate to local & regional RA management for assigned portfolio. 
- Ensures regulatory compliance for a sustainable life-cycle management: manage labeling and CMC changes in accordance with local regulations and relevant global SOPs
- Ensure proper maintenance and update of product licenses in compliance with global standard and local regulations. 
- 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. 
- Manage regulatory activities for clinical trials based on documentations provided from global regulatory affairs and in accordance with local regulations.  
- Monitor and timely communicate upcoming regulation or policy changes for assigned area including preliminary impact analysis.


Qualifications / Requirement

- Bachelor's Degree in Pharmacy
- 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

 “신체적 조건과 출신 지역, 혼인여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직원, 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.”