Wednesday, May 18, 2022
HomeB.Pharmacy JobsJob opportunity for Regulatory Affairs at M J Biopharm Pvt Ltd

Job opportunity for Regulatory Affairs at M J Biopharm Pvt Ltd

Greetings from M J Biopharm

We are hiring following positions

Executive/Senior Executive in Regulatory Affairs

Job location: Nariman Point, Mumbai
Experience Required: 3-6 years of experience

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



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

  • M.Sc/ B.Pharm/ M.Pharm 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 or can contact on 9619744167.


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