Ryvis Pharma Pvt. Ltd – Openings for Regulatory Affairs – Apply Now

Ryvis Pharma, we strive to make the highest quality products at affordable prices. Since entering the pharmaceutical industry over two decades ago, we have become a torchbearer in globally competitive high-quality FDA approved products.

Company Name: Ryvis Pharma Pvt. Ltd.
Industry: Pharmaceuticals
Office Location: Andheri (E), Mumbai, India

Roles and Responsibilities:

  • To prepare and review the dossiers in the format of CTD / ACTD and specific formats as per the respective countries guidelines.
  • Responding to queries raised by MOH of the above regions in the stipulated time frame.
  • To be able to coordinate with plants to get the Dossiers/Technical documents and samples of products for registration.
  • To review the technical the documents for preparing the dossier.
  • To review the artworks and get approval on the same from the plants.
  • To check the availability of the documents and able to evaluate the documents at different plants.
  • To have a good knowledge of CTD & ACTD formats.
  • Well versed with ICH Guidelines.
  • To conduct reference study search in libraries / Internet for accumulating comparative technical data of various formulations.
  • To check the compliance status of the Quality Systems followed at the manufacturing site in line with the submitted dossiers.
  • To evaluate and comment on the requirements of BE/Clinical studies.
  • Should be able to prepare raw data for the dossier.

Skills and Qualifications:

  • B-Pharma/M-Pharma Candidates can apply
  • Preferably 3-4 years of experience in DRA Department
  • Experience with ACTD/CTD Dossiers.
  • Exposure to Drug Regulatory Affairs.
  • Good Knowledge of ICH guidelines.
  • Technically Comprehensive.
  • Fine Analytical Skills and Systematic approach.
  • Proactive approach to problem-solving.
  • Good computation Skills.
  • Strong and consistent.
  • Logical Interpretation of Data.
  • Ability of multi-tasking.
  • Fluent in English (Speaking, writing, reading, and understanding)
  • Computer Skills (Ms. Excel, Ms. Word, Internet, Email

Kindly share your CV at hrdept@ryvispharma.com

 

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