Analyst III Regulatory Publishing

Job Description:

• 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

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