Regulatory affairs

Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.

B. Pharma / M.Pharma. Review and submission of injectable product dossiers for TGA and Europe in CTD, ACTD formats.

B.Pharm / M.Pharm. Regulatory Affairs Assistant Manager Europe Market. regulatory pathways for EU submissions and can compile EU eCTD dossier

Post graduate in Pharmacology or Regulatory science or a related field. experience in regulatory science, product development, clinical trials, or related fields.

Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry

BPharm, MPharm, Pharm D, or MSc. Regulatory Affairs and Submissions Management.

Monitoring for Documents compilation activities for New product filing , Re-Registration, renewals from plant dossier filing , sample requirements etc. Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.

RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate

Bharat Parenterals Ltd. is a Gujarat based pharmaceutical company, established in 1992 by Mr. Ramesh Desai, who started the company with a vision of making world class affordable medicines and to take it to the forefront of contract manufacturing units in Gujarat.