REGULATORY AFFAIRS/EXPERIENCE-BULK DRUGS/API-HYDERABAD
Department: Regulatory
Affairs
Designation:
Executive/Sr. Executive
Industry: Pharma/API
Experience:
2 to 6 years
CTC: Negotiable
Job
Location: Sanath Nagar, Hyderabad
Roles and
Responsibilities
- 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.
- Preparation of pharmaceutical ingredients (API)
and its intermediates.
- Analytical interpretation, trouble shooting
& Plant performances.
Desired Candidates Please Share Your Updated Resume vivek.s@heterodrugs.com
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