Executive Assistant

8.00 to 13.00 Years Delhi 07 Nov, 2023

Job Location	Delhi
Education	Not Mentioned
Salary	Rs 14 - 18 Lakh/Yr
Industry	Pharma / Biotech
Functional Area	Bio Tech / R&D / Scientist
EmploymentType	Full-time

Job Description

Urgent Opening for Executive / Sr. Executive / Asst. ManagerManager / Sr Manager for Pharmaceutical IndustryQualification -B. Pharma / M.Sc. / M. PharmaExperience 8 YearsDepartment - Scientific Intelligence Group - Regulatory AffairsDosage - Injectable / SterilePreferred Industry Pharmaceutical, LaboratoryUSA Market experience is mustOnly Male Candidate Job Description Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables thatmay include Peptides, Microspheres, Liposomes, Nanosuspensions etc./ Ophthalmic/ Otic/Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.Draft, Review and Finalize PreANDA/PreIND/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 invitro 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 regulatoryrequirements for Complex products.Contact hidden_mobile chanchal.v@mnrsolutions.in or neeraj.shukla@mnrsolutions.in

Keyskills :
sterileregulatory affairsinjectablendapre approvalusa market

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Executive Assistant

Job Description

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