Regulatory Affairs Manager (CH RA Lead)

Regulatory Affairs Manager (CH RA Lead)

[Your Tasks and Responsibilities]

- Contribute to business and regulatory objectives with APAC CH RA Head in implementing local regulatory strategic matters to fulfill the local business strategies in alignment with functional line manager. Ensures transparent, timely and efficient communication with business, supply chain and other local functions, regional/global Regulatory Affairs, providing regulatory expertise to achieve common decisions. Responsible for timely communication and alignment of regulatory timelines and strategies with local cross-functions in close cooperation with APAC CH RA Head and Global Regulatory Affairs.

- Ensures early identification of conflicts between projects and transparent and  aligned prioritization where applicable:

    a) Report the identified conflicts to APAC CH RA Head timely in order to meet country’s regulatory needs.

    b) Ensures the preparation of the application files for products based on the documentation provided from global regulatory partners in accordance with local regulations, are of acceptable standard and quality to present them to the respective authorities. Liaise with Regional and Global Regulatory Affairs to obtain data required in support of registration applications to answer health authority queries.

- Able to manage assigned portfolio (e.g. preparation and submission of new applications, new indications, and post-approval variations) and follow through from submission to approval. Provide regulatory gap analysis, timely communicates to related functions & APAC CH RA Head.

- Where applicable, liaise with third parties/distributors/agents in relation to registration activities.

- Ensures regulatory compliance for a sustainable life-cycle management: Labelling and CMC changes are performed in accordance with local regulations and relevant Bayer SOPs.

- Ensures proper maintenance and update of product licenses in compliance with global standard and local regulations. Review packaging texts to ensure compliance with registration and legal requirements. Approve packaging artwork as necessary.

- Maintains global regulatory databases accordingly. Maintains product archiving of assigned portfolio in accordance to global/local SOP or OI: approvals documentation, correspondences filing and local dossier archive.

- Provides local RA intelligence: Identifies current and emerging national regulations which impact the drug development and / or marketing processes and ensures appropriate contribution and communication according to assigned responsibility.

- For assigned portfolio or projects, support LQR by providing regulatory expert input for LQR to manage product complaints, recall process, health authority interaction and communications including health authority inspections as locally relevant. Provide necessary functional input and documents to enable LQR to complete local compliance checks and develop local QSD process.

- Support and coach team members, conduct performance reviews, development dialogue etc. at required intervals.

[Qualifications / Requirement]

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

- Proven experience in regulatory or drug/food supplement/cosmetics development experience in  consumer health industry.

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

- Convincing presentation skills are required. 

- Able to demonstrate good cross-functional communication skills.

- Ability to propose solutions while dealing with various environment aligned with APAC CH RA Head.

- Ability to focus on multiple issues at one time, ability to organize, prioritizes and direct diverse activities in changing environment often under time pressure.

- Ability to develop effective solutions to business problems, recognizing business needs, thinking strategically and develop risk mitigation strategies.

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

- A team player with ability to work in a team environment an possess strategic thinking and solution orient mindset.

- Pro-active approach with focus on adding value to the business.

[근무조건]

근무형태: 정규직

근무요일/시간: 주 5일(월~금)
근무지역: 서울

급여: 회사내규에 따름

[안내사항: 전형, 제출서류, 접수방법]

 전형방법

   - 1차 서류전형, 2차(3차) 면접전형

 제출서류

   - 국문/영문 이력서, 자기소개서 (각종 증빙서류는 면접전형 합격자에 한해 추후제출)
지원방법

   - www.bayer.co.kr 로 접속하여 인재채용 – 채용공고 란에서 온라인 지원
     (이력 및 자기소개서는 온라인 지원시 작성)

[문의사항]

 전화: 02 - 829 - 6511

 주소: (156-010) 서울 동작구 신대방동 395-62 삼성보라매옴니타워

[기타 안내사항]

- 면접은 서류전형 합격자에 한해 개별통지 합니다
- 국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대합니다
- 남자는 병역필 또는 면제자로 해외출장에 결격사유가 없는 자를 모집합니다
- 모든 서류는 반드시 MS Word로 작성하기 바랍니다.
- 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.”