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REGULATORY AFFAIRS - DEPUTY MANAGER

4.00 to 7.00 Years   Indore   09 May, 2022
SYNCOM FORMULATIONS (INDIA) LIMITED
Job LocationIndore
EducationNot Mentioned
SalaryRs 4.5 - 7 Lakh/Yr
IndustryPharma / Biotech
Functional AreaLegal Practice
EmploymentTypeFull-time

Job Description

    Job Profile -hidden_mobileydphidden_mobile2MsoListParagraphCxSpFirst >CTD & ACTD dossier preparation, review and their timely submission for ASEAN, African countries(MENA, Central Africa, EWA, Francophone countries etc.) & CIS countries.hidden_mobileydphidden_mobile2MsoListParagraphCxSpMiddle >Co-ordination with plant / QA / R&D / QC for timely catering to documents / sample requirements for regulatory submissionshidden_mobileydphidden_mobile2MsoListParagraphCxSpMiddle >Review & archival of datahidden_mobileydphidden_mobile2MsoListParagraphCxSpLast >LifecycleManagement ofapproved drug products:hidden_mobileydphidden_mobile2MsoNormal >a. Timely preparation and submission of annual reports/renewals.hidden_mobileydphidden_mobile2MsoNormal >b. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplieshidden_mobileydphidden_mobile2MsoNormal >c. Regulatory Compliance- Ensure timely implementation of regulatory decisions for change management and other activities in DF plants.hidden_mobileydphidden_mobile2MsoListParagraphCxSpFirst >Review Artwork and Label as per respective country guideline.hidden_mobileydphidden_mobile2MsoListParagraphCxSpMiddle >Self-Development:a. Reading regulatory guidelines, participating and delivering presentations.hidden_mobileydphidden_mobile2MsoListParagraphCxSpLast >Any other tasks assigned by managementhidden_mobileydphidden_mobile2MsoNormal >

Keyskills :
regulatory affairsrenewals

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