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
Job 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)
Essential 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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