Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Job Description
Preparation & review of US ANDAs/ 505(b)2/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses regulatory strategy note controlled correspondences Briefing books labeling artworks and ScA meeting packages. Coordinate with internal stake holders (R&D AR&D SCM FTO CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records specifications analytical method Stability protocols PVPs etc).In coordination with eCTD / labeling team ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines.
Qualifications :
M. Pharm PhD
Additional Information :
Good communication skill (Written and Oral) Selfstarter with a gogetter attitude and team player Quick learner and able to prioritize information Good interpersonal skills High level of proficiency in networking internally and externally.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
