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Hetero Drugs Recruitment for Regulatory Affaris-Executive/Sr.Executive

SWARNALATHA B February 20, 2021

Hetero Drugs Limited Recruitment 2021. Hetero Drugs Limited Notification full detailes below. Hetero Drugs Limited. Limited is one of India’s generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. 

Important Vacancy details:

  1. Post Name: Regulatory Affaris-Executive/Sr.Executive
  2. Education: M.Pharma,M.sc
  3. Experienced:2 t0 6 years
  4. Location: Hyderabad
  5. Salary: INR 2,00,000 – 6,50,000 PA.
  6. Openings:NA

Note:If interested candidates can share your resume to mentioned mail ID Below.

vivek.s@heterodrugs.com

 Job Description: Hiring For Regulatory Affaris-Executive/Sr.Executive in Hetero Drugs Limited.!  If interested candidates can share your resume to mentioned mail ID 

vivek.s@heterodrugs.com

  • Preparation of Drug Master Files (DMF) in CTD / eCTD / Nees format for US, European Countries, Canada, Australia, Japan, GCC, Turkey and Korea as per customer/ business requirement.
  • Preparation of amendments/ Annual Reports to USDMFs, CEP variations, EDMF Updates, Biannual updates to Canada DMFs and Annual updates to Korea DMFs, Japan DMFs.
  • Review and approval of change controls.
  • Submission of notifications to the customers pertaining to regulatory submissions as per the applicability.
  • Responding to deficiency letters received from various regulatory agencies like USFDA, EU Agencies, TGA, Health Canada etc.
  • Hands-on experience in Electronic submissions-Lorenz.
  • Maintaining query database and response timelines.
  • Tracking of variation submission timelines (Amendments, Annual Reports) to various Health Authorities
  • Responsible for organizing meetings to address queries and variation submissions.
  • Rendering customer support by preparing technical packages, Applicant” s Part Drug Master Files and responding to the technical queries received from customers.

2 years worked in organic synthetic research (PR&D) with pilot plant.

  • Preparation of pharmaceutical ingredients (API) and its intermediates.
  • Analytical interpretation, trouble shooting & Plant performances.

Selection Process: The selection will be on the basis of Interview.

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SWARNALATHA B

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