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3.0 - 5.0 years
3 - 6 Lacs
hyderabad
Work from Office
Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle) Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents. Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents
Posted 1 week ago
6.0 - 11.0 years
10 - 18 Lacs
hyderabad
Work from Office
Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...
Posted 1 week ago
4.0 - 6.0 years
3 - 5 Lacs
Mumbai Suburban
Work from Office
Exp.: Min 4 to 5 years Designation: Executive- Regulatory Affairs Location: Mumbai Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals Other essential skills: LATAM/ GCC/ MENA/ SEA/AFRICA/ change control/ Art work checking Job description: Common requirements: 1) Complete understanding of requirements & regulations of ASEAN/ AFRICA/LATAM/ GCC/ MENA markets wrt New submissions, Re-registration & Variations. 2) Prior experience of carrying out high quality CMC review of all kind of technical documentation & Art-works, 3) Review and /or Compilation of country specific/ CTD/ACTD dossiers for new submissions & renewal. 3) Variations submission 4) Mus...
Posted 3 months ago
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