MJ Biopharm Pvt Ltd Job Vacancy For MSc/ B.Pharm/ M.Pharm

MJ Biopharm Pvt Ltd Job Vacancy For MSc/ B.Pharm/ M.Pharm 

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