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• Contribute to business and regulatory objectives with RA KR Management 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 & RA KR management in close cooperation with Regional Regulatory Managers and other Global Regulatory units.

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

a) Report the identified conflicts to RA KR Management timely in order to meet department¡¯s regulatory needs.

b) Ensures the preparation of the application files for products based on the documentation provided from GRA 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 (eg. preparation and submission of New Chemical Entities (NCE), new indications, new presentations, post-approval variations) and follow through from submission to approval.

• 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 archivings 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.

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• Life Sciences based BS or MS with requisite experience and demonstrated track record. Preferably have more than 3 year-experience in regulatory or drug/biologic development in global pharmaceutical 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.

• Agility and readiness to learn and seek own solution. Analytical capability to evaluate complex situations and to proactively identify potential issues and future trends, translate and apply them to assigned portfolio. Ability to propose solutions while dealing with heterogeneous environment aligned with RA KR management.

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

• 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.