24/03 Neeraj Shukla
Senior Talent Acquisition at MNR Solutions

Views:144 Applications:4 Rec. Actions:Recruiter Actions:0

Executive/Senior Executive - Regulatory Affairs - Pharma (3-8 yrs)

Ahmedabad/Gujarat Job Code: 21371

Department - Regulatory Affairs

Function - Pre Approval

Dosage - OSD (Tablet / Capsule / Topical)

Designation - Executive / Sr. Executive

Qualification - B. Pharm / M.Sc. / M. Pharm

Job Description :

- Evaluate change controls and formulates strategies for correct filing categories, with guidance from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.

- Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.

- Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.

- Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.

- Proactively raises major project issues to superior for resolution and agreement.

Note - USA Market experience is must

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