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:
- Post Name: Regulatory Affaris-Executive/Sr.Executive
- Education: M.Pharma,M.sc
- Experienced:2 t0 6 years
- Location: Hyderabad
- Salary: INR 2,00,000 – 6,50,000 PA.
Note:If interested candidates can share your resume to mentioned mail ID Below.
Job Description: Hiring For Regulatory Affaris-Executive/Sr.Executive in Hetero Drugs Limited.! If interested candidates can share your resume to mentioned mail ID
- 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.