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¿ÜÀÚ»ç-Regulatory Affairs Manager¸ðÁý
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Work closely with Head of RA PH KR in setting and leading local regulatory strategic and operational matters of assigned portfolio or projects to fulfil the local business strategies, in consultation with local stakeholders, Regional RA Heads and other Global regulatory units for functional alignment. 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. Effectively manages priorities within responsible team and lead or perform regulatory projects by themselves based on resource analysis and project priority.
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• Good experience of establishing local regulatory strategy and scenario (especially local bridging strategy etc) aligned with overall phase of global development strategy
• Good capability to provide local regulatory feedback for the label of global pipeline, understanding and considering the correlation between local label and local reimbursement strategy
• Excellent capability for scenario planning for issue mitigation during registration or marketing of product (eg. GMP issue with supply impact, local issue mitigation considering supply issue etc)
• Bachelor or Master¡¯s Degree in Life Sciences or equivalent scientific degree with a minimum of 7-10 years pharmaceutical industry experience in regulatory affairs
• Excellent interpersonal, communication and negotiation skills. Good managerial and leadership skills
• Ability to come up with effective solutions, deal with issues and develop risk mitigation strategies with strategic thinking.
• Profound knowledge of local regulations and regulatory framework of International Standards (e.g. US/EU, ICH, GCP, GMP) and regulatory experience related to registrations, post-approval variations, regulatory due diligence and compliance.
• Fluent in English. Excellent English communication skills both orally and in writing.
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