Sun Pharmaceutical Released Job Openings On 16-09-2021. Sun Pharma beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Application form link provided at the end of post.
Vacancy Details:
Sun Pharmaceutical Recruiting B.sc, MSc, M.Pharm with 04-07 Years experience for Regulatory Affairs Compliance position.Complete Details for the Regulatory Affairs Compliance as follows.
Important Details :
- Location :Mumbai
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: ₹ 8,00,000 – 12,00,000 P.A.
- Opening date for online Application: 16/09/2021
- Mode of application :Online
Job Description/Skills Required
This position will work closely with a globally distributed submission team (US and India) to produce quality submissions, meeting tight timelines. The individual will collaborate often with GRA Strategist\Coordinators located in both US and India. This individual will liaison and support the global functional area document management process to safeguard timelines for the company’s regulatory submissions.
- Collaborate with GRO, GRA, project managers, functional team members
- Publish, review, submit and archive global eCTD submissions, using Regulatory Affairs systems/tools
- Effective timeline management and communications relative to submission components
- Support GRA Strategist/Coordinator activities
- Assist functional areas with document-level requirements and best practice techniques for compliant authoring
- eSubmission Document preparation
Technical Skills
- Knowledge of and experience using an integrated document management and publishing system.
- Experience submitting submissions via FDAs ESG.
- Expert using MS Word and Adobe Acrobat functionality. iSiToolbox know how is a plus.
- Knowledge of and experience in document-level template formatting and publishing. Template creation is a plus.
- Knowledge of the pharmaceutical industry and regulatory documents.
- Understanding of the CTD structure as well as FDA and ICH specifications for eCTD submissions.
- Document formatting.
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