Assistant - Regulatory Publishing

6 days ago

Bengaluru Karnataka, India DXC Technology Full time

Successfully meet/ complete training milestones relevant to the position held.
- Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry
- Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and 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-Developments 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
- Bachelor’s degree in life sciences specialty (pharmaceutical /biotech) years of Regulatory Publishing experience
- Minimal supervision required for common publishing tasks

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