Sr Executive - Regulatory API
Job Description:
Job description for API Regulatory:
- Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP.
- Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates).
- Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data package to customers.
- Handling of DMF deficiencies received from regulatory agencies with coordination of the cross functional teams within the stipulated time.
- Handling of customer queries related to DMF / Product.
- Preparation, review and submission of Letter of authorization / Letter of access (LoA) to regulatory authorities & customers.
- Review of changes for the DMF filed products w.r.t regulatory point of view.
- Supporting the regulatory / customer audits.
- Hands on experience on eCTD guide lines and update with the current guide lines.
- Experience: 4-5 years
- Job location Thane
Key Skills :
Company Profile
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At ------ --- ---, the "right" job is one in which your values are being satisfied most effectively. If career growth and advancement are your primary goals, and they're represented by how much you earn, then the job that pays the most money is the "better" job.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.