Sr. Manager - GCMC(美资制药企业）招聘_领拓咨询最新招聘信息-猎才医药网

职位描述

职位描述：工作地点：苏州 / 上海 / 北京Core responsibilities include but are not limited to:?Possess a high level of understanding of the technical/regulatory aspects and product characteristics that impact CMC regulatory strategy of assigned products?Ensures CMC contents are accurately and completely prepared/authored to support:oIntroduction of a new commercial product, including new market introductions for existing productsoPost-approval changesoLicense maintenance (ex. Renewals, annual reports, gap closures)?Ensures that submission related deliverables are provided in accordance with project timelines.?Participates in the review and approval of newly authored submission content?Performs functions within the PDM (Product Dossier Manager) system for changes impacting the specific global portfolio of products under his/her responsibility.?Develops and communicates regulatory strategies (product & project-level) that identify regulatory risks & mitigation strategies and align with development and/or commercial plansoBalancing regulatory requirements, constraints and risk posture with WSR, PGS, & Consumer Business goalsoLeverage diverse GCMC expertise and experience (regionally and globally) to share and incorporate learnings into future CMC strategies & submissionsoDevelop robust CMC/Regulatory strategies and submission plans that provide fit for purpose regulatory submissions that will deliver market approvalsoCommunicate CMC strategies, regulatory risks and mitigation plans to PCOs in alignment with GCMC “One Voice” . Influence PCO/HA to adopt innovative CMC strategies, when neededoUse in-depth knowledge of country-specific pre- and post-approval CMC regulations to identify, interpret and apply local CMC requirements, in assigned regionoidentify country-specific/regional CMC requirements and opportunities to “bundle” changes to reduce PCO submission volumeoIdentify, assess impact & proactively communicate changes to local regulationsoEnsure local submission plans and forecasts meet GCMC, WSR, & PGS objectives and requirements?Interacts with PGS, WSR, WSRO and Commercial to ensure effective communication and management of regulatory information and documentation for regulatory conformance and Consumer product life cycle management.?Identifies and escalates regulatory conformance issues to the appropriate Leadership?Provides regulatory support and assistance to technical groups within the region or market.?Provides assistance to special projects requiring CMC Regulatory input, including due diligence activities in business development opportunities.?Drives and leads discussions related to queries from Health Authorities, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.?Where necessary, provides assistance to internal compliance audits and assists in developing appropriate responses and action plans to address audit observations.?Fosters a culture of strong performance, assuring team objectives are met and in alignment with business goals.?Participates in Operational Excellence initiatives to identify and implement continous improvement strategies; tracks and reports progress. Assists in the determination and sharing of best practices across the organization.EDUCATION AND EXPERIENCE:?Advanced degree (MS, PhD, Pharm. D.) with a minimum of 4 years of relevant experience, or Bachelors degree with a minimum of 6-8 years of relevant experience is required.?Managing cross-border relationships highly desired?Prior experience managing projects is required?Comprehensive understanding of CTD format, content and requirements of Drug Product in China is highly desirable?Minimum of 4-5 years of relevant hands-on Regulatory CMC experience (ex. authoring for initial or post-approval variations for marketed products) is highly preferred?Regulatory experience with different Consumer submission types in China (Drug, OTC, food, cosmetic, etc.) is highly preferredTECHNICAL SKILLS REQUIREMENTS:?Experience working in the Pharmaceutical manufacturing industry, knowledge of pharmaceutical development processes and cGMPs is required.?Excellent English writing and oral presentation skills is mandatory.?Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.? 职能类别：药品注册关键字： CMC

公司信息

In 1992, Linktop Group was originally founded in Sydney, Australia. After years of elaborate operation and steady development, Linktop has to date expanded into an international group of companies with subsidiaries and representatives in Australia, New Zealand, Singapore, Canada and China etc.In 1995, Linktop Consulting started executive searching business. With experienced professional experts in HR fields, Linktop remains committing to provide the highest possible standards of professional supports and solution-oriented service to its valued clients in all kinds of industries.

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-10

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