• Decides on local regulatory strategic and operational matters to fulfill the local business strategies for the PH portfolio, in coordination with the local functions and with close coordination with Regional Heads and other Global regulatory units.
• Delivers Regulatory Affairs Milestones for Taiwan.
• responsible for Regulatory compliance: Supports and implements change management activities regarding pharmaceutical quality in cooperation with disciplines and Global RA.
• Responsible to represent Bayer as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels.
• Provides local RA intelligence: Identifies current and emerging national regulations which impact the marketing processes including competitor intelligence. Ensures appropriate contribution and communication with all involved areas.
• Ensures agreement of Health Authorities to Bayer’s Regulatory strategies, Provides active contribution to development of measures in order to increase approval chances based on a solid knowledge of drug development, Building relationships with the Health Authorities, as key customers, is essential in achieving business goals, Strategically influence the regulatory environment to ensure success of future projects.
- 1 人
- -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
- Excel、Internet Explorer、Outlook、PowerPoint、Word
- • Master’s Degree in Life Sciences or equivalent scientific degree with a minimum of 7-10 years pharmaceutical industry experience in regulatory affairs with at least 5 years of proven leadership role experience in health authority interactions and negotiations, in managing projects and demonstrated track record of providing workable solutions to complex regulatory problems.
• Analytical capability to evaluate complex/ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases.
• The successful candidate will have the requisite experience to act as an effective business partner to country commercial organization.
• Fluent in English and local language. Excellent communication skills to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills to represent the company at external meetings and report issues, strategies and activities to TW country management team and RA global/regional management of Bayer.
• Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
• Good working knowledge of regulatory framework in EU, US and International Standards (e.g. ICH, GCP, GMP) highly desired.
• Job title is subjected to the candidate’s qualification.
1) 上班五天,週休二日 2)年休假12天 3) 享勞、健保及團體保險 4) 年度員工旅遊及中秋、端午禮金 5) 提供完善之人才培訓計劃
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