M. J. Biopharm– Openings in Regulatory Affairs MSc/BPharm/MPharm
About M. J. Biopharm
With a rich heritage of more than 20 years, MJ Biopharm is a biopharmaceutical company that produces medical formulations for combating a plethora of ailments. MJ Biopharm is a reliable name for life-saving products against diseases such as Diabetes, Cardiovascular, NSAIDS and antibiotics. Over the years, MJ Biopharms core innovation and focus has been channelized in manufacturing of biosimilars & biopharmaceuticals formulations. Currently, MJ Biopharms pharmaceutical formulations are accredited & sold in more than 30 countries globally
Executive/Senior Executive in Regulatory Affairs
Job location: Nariman Point, Mumbai
Experience Required: 3-6 years of experience
1.Project Management for life-cycle of regulatory submissions
2.Preparation and Submission of the Dossiers as per CTD/ACTD/Country Specific guidelines as per assigned timelines
3.Understanding of ICH guidelines
4.Review and approval of artworks as per the Regulatory requirements.
5.Responding to queries raised by regulatory authorities or customers
6.Inter Department coordination to arrange documents and samples for Regulatory Submission. Review of documents before adding to dossier.
7.Preparation of documents for application for Brand Approval, COPP and country specific FSC.
8.Preparation of Custom Clearance Documents for Dossier and sample dispatch to client or authority country specific.
9.Preparation of documents for domestic and international tenders
10.Archival of Data and Preparation of Compliance Dossier post Registration.
11.Opportunity to work on the Sponsor-side of Clinical Trial Management (involves working with a CRO)
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
Experience with biosimilars is an advantage.
Interested applicant can send their CV on firstname.lastname@example.org