Hetero Labs Limited Walk-in Interview 2021. Hetero Labs Limited Notification full detailes below.Hetero Labs Limitedd is one of India’s generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs.
Important Vacancy details:Hetero Labs Limited We Are looking for Regulatory Affairs-Executive/Sr.Executive At india-Hyderabad -Interested and eligible candidates can Apply Now.Interested candidates please mail cv to firstname.lastname@example.org
- Department: Regulatory Affairs-Executive/Sr.Executive
- Qualification:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
- Experienced: 4-8 years
- Location: India-Hyderabad
Job Description:We are hiring Freshers for Regulatory Affairs-Executive/Sr.Executive.
Experience:4 to 8 years
- 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.
- Analytical interpretation, trouble shooting & Plant performances.
Desired Candidates Share your Profile to email@example.com
Selection Process: The selection will be based On Interview.