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Hiring for Regulatory Affiars

3.00 to 8.00 Years   Hyderabad   31 Mar, 2021
SMS Pharmaceuticals Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryRs 1.0 - 4.0 Lakh/Yr
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

Dear candidates,Greetings,We have and Urgent Opening forProfile: Regulatory Affairs Department (vd MPharm & Pharma-Formulations exp. of US/EU, regulated markets in India)Work Location: HyderabadExperience: 5 yearsJob descriptionResponsibilities- Relevant formulation experience in Regulatory Affairs for EU / US submissions with following expertise

  • Author high quality CMC documentation for EU / US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.
  • Identify the required documentation for US regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Review and Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues proactively.
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical tre.
  • Coordination with stakeholders on a regular basis to extend all technical support required from regulatory perspective.
  • Actively participate as a member by contributing to the regulatory strategy, identifying critical issues and lessons learned.
  • Hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
If interested pls specify the skill set in the subject line & provide the following details along with a copy of your resume onhr@smspharma.comCurrent CTCExpected CTCNotice PeriodCurrent LocationRegards,Team HR

Keyskills :
us marketeuroperegulatory affairs associate

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