HomeRegulatory AffairsOfficer/Executive - Regulatory Affairs | Medreich Ltd | Bengaluru

Officer/Executive – Regulatory Affairs | Medreich Ltd | Bengaluru

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Medreich has an advanced state of the art Research and Development center with proven scientific competence to develop formulations as Patent Non-infringing and Niche generics in differentiated dosage form for global regulated markets.

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Medreich has in-house capability to ensure regulatory compliance in regulated markets across the globe.

The company is manufacturing formulations in various dosage forms for MNC’s like GSK, Pfizer, Sanofi, Novartis, Mylan, Apotex, Adcock Ingram, and many other customers across 55 countries in key markets of Europe, Australia & New Zealand, Canada, Japan, Far East Asia, GCC, Africa, LATAM and CIS.

“Winning is the most important component to us and we believe when working towards one’s personal best, one is actually competing by oneself.”

At Medreich, our value statement Winning Together further strengthens the winning behavior as we believe in working together as a team to scale greater heights.

Position: Officer/Executive – Regulatory Affairs

Location: Bengaluru, Karnataka, India

Job Description:

  • To review and enhance the quality of documents related to the new product development which includes API/Excipient/FP Specifications and MOA, Stability protocol, MFR, BMR, BPR, PDR, CDP & Elemental impurity justification, etc
  • To review and ensure the correctness of filled BMRs, filled BPRs, API/Excipient/Packing material/FP Specifications and MOA, Stability reports, Process validation report, Method validation report, CDP & PDR, etc.

  • Coordinate with different departments to ensure the availability of all the documents related to the exhibit batches for registration dossier compilation within stipulated timelines.
  • To follow up with different departments on any pending documents requests/issues.
  • Review & Ensure of all the development documents meeting the regulatory requirements
  • Review of registration dossiers
  • Drafting response for customer and agency queries
  • Single point of contact for test license, Import permit, and Manufacturing license application
  • Timely follow up for stability data from stability department and sharing the same to respective customers.
  • Performing other activities based on the need as assigned by Head RA.

Qualification: M.Pharma

Experience: 4-8 Years

Salary: Negotiable

Contact Details:

aravinda.p@medreich.com, sekhar.s@medreich.com

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