: Successfully meet/ complete training milestones relevant to the position held. Familiarity with FDA / 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 up-grading 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 Bacheloru2019s degree in life sciences specialty (pharmaceutical /biotech) 1-2 years of Regulatory Publishing experience
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