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Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration, import license of drugs and medical devices in India. 

As an Associate Global Scientific Advisor, you will Provide timely, accurate and credible scientific and medical input for a variety of projects pertaining to scientific communication around Novo Nordisk’s products. Collaborate closely and communicate effectively with various cross-functional stakeholders including colleagues from the US affiliate, global medical affairs, and other functional areas. Engage in dialogue with Key Opinion Leaders (KOLs) in different settings with focus on medical and scientific information. Prepare presentations for Novo Nordisk standalone events and international medical congresses.

Analytical method development, stability samples analysis and impurities identification by using instruments like HPLC, GC, LC-MS, and other analytical techniques.

Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article. Demonstrates understanding of client’s drugs labels and uses that knowledge effectively when performing the safety assessments.

Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead medical writer. Work with internal or external Clinical and or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.

You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance.

Support the Quality vision and mission for Amgen India aligned with Amgen’s mission to serve patients. Support Amgen India Quality Team Lead in the development and implementation of a multi-year Quality technological plan aligned with Amgens standards and overall strategic imperatives.

HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.

The ideal candidate will be responsible for compiling Drug Master Files DMFs and Certificates of Suitability CEPs, ensuring compliance with global market regulations and emerging market standards in accordance with ICF guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.