Regulator Affairs Manager
印度西普拉有限公司上海代表处
- 公司规模：少于50人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程 医疗/护理/卫生
职位信息
- 发布日期：2017-07-17
- 工作地点：上海
- 招聘人数：1人
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：2-2.5万/月
- 职位类别：药品注册
职位描述
? Co-ordination with regional (India based team), Consultant for Review, translation & submission of all new dossier applications, renewal applications ,variation packages, deficiency responses, justification /explanation letters (to be submitted for prior approval),Site audit applications as required
? Taking guidance from CFDA/CDE/Provincial Authorities & liaising with authority for new submission, tracking of dossier evaluation process , necessary approvals
? Making representations with CFDA/CDE/Provincial Authorities on behalf of Cipla whenever required
? Tracking all the updation in registration guidelines, CFDA’s draft guidance & new requirements. Translating it into good English & percolating evaluation & impact to regional team.
I. Achieve timely submission of dossier and deficiency responses to regulatory authority by reviewing in order to ensure approvals in stipulated time
? Review of all new dossier applications, renewal applications, variation packages, deficiency responses, justification /explanation letters (to be submitted for prior approval), Site audit applications as required
? Submitting all regulatory applications with MOH including new submissions, renewal of already approved products, filing all types of variations, Justification/explanation letters (to be submitted for prior approval), deficiency responses, Site audit applications
? Wherever submission is through consultant - close coordination with consultant for review, translation & compilation of Chinese version of dossier.
? Monitoring consultant activities & providing timely reports
? Co-ordination with translation vendors for translation of API DMF’s open & closed part.
II. Liaison with MOH as required
? Making representations with MOH on behalf of Cipla and any other such activities
? Taking guidance from MOH on exception /critical/out of the guidelines cases to decide path forward
? Applying for and accompanying MOH officials for Site inspections (Manufacturing site/BE centre). Provide assistance and guidance wherever required to manufacturing unit/auditors.
? To maintain the documentation /licenses for legal representation in MOH as required
? Liaising with authority for getting MA’s, necessary approvals
? Assist consultant during submission of new dossier/deficiency response to CFDA
? Frequent visit to CFDA/CDE reviewer for clarity with respect to new draft guidance’s, regulatory queries, strategies for new development etc...
III. Provide support for RA related activities
? To provide updated Chinese Pharmacopeia & CFDA draft guidance.
? Assist in making innovator sample ,PI purchase from respective market if required To aid in procuring and providing the country specific innovator PI wherever required
? To provide translation of PIL/PI of innovator product.
? Help in extracting the archived documents from MOH, if required
? Assist in getting the market information on availability of the products/strengths wherever required
? Assist in finalizing regulatory strategy for new development products.
? Regularly tracking submission progress as displayed on CFDA’s site & providing report of the same.
IV. Provide the regulatory intelligence
? Providing the regulatory/market intelligence on timely manner by sharing the draft guidelines/circulars/amendments/final guidelines published by MOH / Providing strategic advice during new development and registration process/ Keeping up to date with international legislation ,guidelines and company practice
? Assist in IP /trademark related work
职能类别： 药品注册