自贡招聘

职位描述：

JOB PURPOSE:

Manage ongoing registered drug products (OTC and Rx), participate project meeitngs and lead team to register new products by business requirement.

JOB SUMMARY:

· Proficient in drug license maintainance , include: license renewal, variations, new drug registration.

· Proficient in drug license maintainance , include: license renewal, variations, new drug registration etc for domestic and imported drugs, especially for OTC drugs.

· In charge of prepare registration dossiers, Follow up registration procedure,Get final registration permits.

· Follow up registration status, being the contact with local FDA,CFDA,CDE,Chp, inspection agencies and external Pharmacutiecal orgnizations.

· Contact GRA and provide guidance on CFDA requesting documentation and notarizations

· Represents regulatory affairs on cross-functional product/project teams and provides regulatory advice.

· Maintain good relationship with officials;Maintain good relationship with experts. Uses effective communication an employs influencing skills to continue to grow key relationships with internal/external contacts.

· Organize the registration evaluation meeting.Engage the legislator, support registration moving forward sommothly.

· Coordinate Q.C. re-confirmation test with institute for drug control

· Get related registration regulations updated.

· Initiate individual and team develop plans based on business priorities.

· Represents regulatory affairs on cross-functional product/project teams and provides regulatory advice.

· Provide comprehensive regulatory strategy to new product development projects, make sure project on time deliver.

· Develop flawless registration standard procedure and provide effective training to team and internal stakeholders.

· Responsible for people development, performance calibration and career development.

· Plan and manage regulatory submissions ( CTA, NDA) for products within Sanofi CHC portfolio in compliance with corporate standards and local regulatory requirements

· Act as a contact with national regulatory agencies in fulfilling local affiliate marketing authorization obligations

· Assist the LOC Function Head, aligning local regulatory requirements with Sanofi CHC corporate standards

· Assist in the management of the local regulatory function

KEY ACTIVITIES:

· Applying, obtaining and maintaining regulatory approvals for import and local products, including CTA, NDA, Manufacturing License, Variations

· Ensure that regulatory submissions are made on time and meet Sanofi CHC corporate and local regulatory requirements

· Implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements

· Participate in the local implementation of key Regulatory projects

· Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Sanofi CHC products

· Feedback on any Regulatory Intelligence to International Regulatory Affairs

· Support for Therapeu8tic Areas/Scientific Affairs activities

· Where applicable, oversee external vendor/contractor relationships

KNOWLEDGE AND SKILLS

· Regulatory expertise in national, centralized and biotechnology products

· Well understand the procedure with drug registration, test process and regulation requirement from CFDA,CDE,Chp

· Interactions with regulatory authorities

· Working with policies, procedures and SOPs

· Knowledge of national legislation and regulations relating to medicinal products

· Understanding of the registration procedures in Europe.Understanding of drug development

· Experience managing regulatory processes

· Scientific / Technical Excellence

· Supervisory Skills

· Communication Skills: Oral and Written

· Team Work

· Negotiation Skills

· Ability to anticipate and prevent potential issues

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

Bachelor degree in pharmacy

Experience & knowledge:

· Minimum 5 years working experience in pharma. industry

· Over 4-5 years experience in drug registration field

Core competencies:

· Good computer skill in EXCEL, POWERPOINT and WORD;

· Good interpersonal communication skill;

· English skill both in spoken and written

· Team leader

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赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
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赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
  
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

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从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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