24/03 Neeraj Shukla
Senior Talent Acquisition at MNR Solutions

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Executive/Senior Executive/Assistant Manager - Regulatory Affairs - Injectable/Sterile/OSD & 505b2 (8-15 yrs)

Ahmedabad Job Code: 21373

Department - Scientific Intelligence Group - Regulatory Affairs

Function - Pre Approval

Dosage - Injectable / Sterile / OSD & 505b2

Education - B. Pharm / M.Sc. / M. Pharm

Job Description :

- Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano- suspensions etc./ Ophthalmic/ Otic/Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.

- Draft, Review and Finalize Pre- ANDA/Pre- IND/ScA meeting packages for US and EU market.

- Draft and finalize controlled correspondences on complex issues.

- Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.

- Review API and FP in- vitro characterization/sameness reports.

- DMF review for complex APIs as per the workflow.

- To collaborate and work closely with cross functional teams.

- To meet the management expectations w.r.t timelines and quality.

- To work closely within the team and provide training to new members on new regulatory requirements for Complex products.

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