POSITION : DEPUTY MANAGER/ MANAGER – REGULATORY AFFAIRS
Desired Qualifications: M.Sc Or Ph.D. (organic / Analytical Chemistry)/ B.Pharm
Desired Work Experience: 8-15 yrs
Job Description/Responsibilities:
Experience in independently developing and writing Drug Master Files (DMFs)/ Common Technical documents in eCTD specifications for US, Europe, Canada, MCC, Japan and other International regulatory agencies (for APIs and Drug products), Certificate of Suitability submissions to EDQM
Submission of Annual Updates and Amendments to DMFs/ eCTDs Experience in handling, preparation and responding to Regulatory / Customer Queries and deficiency letters
Well Experienced in filing NDA, ANDA and INDs
Exposure to Dossier development for Formulated Products to South East Asian countries and other non-regulatory countries (KFDA, IDL applications for registrations of APIs in China)
Knowledge and experience in licensing activities (DCA/FDA, DCGI)
Knowledge / Awareness of regulatory guidelines (viz. ICH, FDA, CTD, eCTD and MHRA)
Capability to face/organize regulatory agencies audits
Expertise in reviewing R&D data, analytical data and other DMF related requirements with feedback capability to comply with the requirements
Zeal to train personnel in the organization from regulatory perspectives
To apply, contact :- +91 40 23420500 / 23420501 or email :- hrd@aptuitlaurus.com
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