Please refer to the below details.
Successfully meet / complete training milestones relevant to the position held.
Familiarity with FDA, GCPs, ICH guidelines, Life Sciences & Pharmaceutical industry
Familiarity of health authority procedures / guidance regarding electronic submissions
Perform submission publishing, assembly, and distribution activities within the specified training period
Notifying relevant stakeholders that the file is ready for approval
Multi-skilled on all allocated submissions within the team
Adapting and willing to multi-skill and assisting in other submission / task within the team
A high level of independent judgment / action in problem solving
Keeping Team Leader informed of non-routine issues, making recommendations to resolve these issues
Self-Development and Take Responsibilities for the same
Active involvement in projects and quality / change initiatives
By continually upgrading domain knowledge
Following company rules and standard operating procedures
Adhering to all Security Policies and Procedures
Promoting a positive and professional image of the team always
Need to abide to the existing Information Security Policies and Procedures
Bachelor s degree in life sciences specialty (pharmaceutical / biotech) 1-2 years of Regulatory Publishing experience
Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
Experience with various document types (CSR, CMC, Nonclinical, CRF) and applications (IND, NDA, ANDA)
Familiarity of health authority procedures / guidance regarding electronic submissions.
Some global application experience (US, EU, etc.)
Minimal supervision required for common publishing tasks.
Analyst • Bengaluru, Karnataka, India