DRA

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

Masters degree in pharmaceutical sciences or Masters degree in other life sciences. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.

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

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.  Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.