Senior Regulatory Affairs Associate
India, Remote 职位编号 R0000040066 类别 Consulting关于这个职位
US & Canada Annual Report
- Compile list of Annual Reportable or Submitted/Approved CMC Changes.
- Strategy/Alignment Meetings (either actual meeting or e-mail exchanges).
- Prepare/Populate CMC Submission Content Plan (“SCP”) Preparation & Submission.
- Activities Module 1 authoring Liaise with appropriate functions to collect all required information to submit.
- Populate the SCP, including e-CTD attributes.
- Liaise with Regulatory Operations to ensure the publishing order and dispatch of CMC Dossiers.
- Follow-up with the Country Regulatory Manager (Affiliate) regarding receipt, submission, and acknowledgement by the Health Authority.
- Store all CMC Dossier and Administrative Documents in the appropriate repository system and close Regulatory Events in RIM.
- Simple Report includes up to 20 reportable changes and Complex Report includes up to 40 reportable changes.
Ideal Candidate Profile
- 5+ years of experience in Regulatory Affairs (Pharma).
- Understanding of US & Canada regulatory requirements for pharmaceuticals.
- Experience in module 1 authoring.
- Ability to handle multiple projects and meet submission deadlines.
- Comfortable working in a fast‑paced, compliance‑driven environment.
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