MJ Biopharm Pvt Ltd Job Vacancy For MSc/ B.Pharm/ M.Pharm
Executive/Senior Executive in Regulatory Affairs
Job location: Nariman Point, Mumbai
Experience Required: 3-6 years of experience
Description:
Project Management for life-cycle of regulatory submissions
Preparation and Submission of the Dossiers as per CTD/ACTD/Country Specific guidelines as per assigned timelines
Understanding of ICH guidelines
Review and approval of artworks as per the Regulatory requirements.
Responding to queries raised by regulatory authorities or customers
Inter Department coordination to arrange documents and samples for Regulatory Submission. Review of documents before adding to dossier.
Preparation of documents for application for Brand Approval, COPP and country specific FSC.
Preparation of Custom Clearance Documents for Dossier and sample dispatch to client or authority country specific.
Preparation of documents for domestic and international tenders
Archival of Data and Preparation of Compliance Dossier post Registration.
Opportunity to work on the Sponsor-side of Clinical Trial Management (involves working with a CRO)
Qualifications/Skills
MSc/BPharm/MPharm candidates with relevant experience may apply
Exposure to Oral Solids and Injectables strongly preferred
Very good written and oral English Language skills
Very good project management, organization and time-management skills
Positive attitude
Experience with biosimilars is an advantage.
Interested applicant can send their CV on shital@mjbiopharm.com
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