Novartis Biology Job – MSc & BSc Candidates Apply
Novartis is a global pharmaceutical company committed to improving the lives of people around the world. As a leader in the generics and biosimilar medicine market, Novartis is dedicated to providing affordable and high-quality healthcare solutions. We are looking for motivated individuals to join our team and contribute to our mission of making a difference in the world.
Job Description
Key Responsibilities
- Preparation of regulatory life cycle maintenance submissions – variations, renewals and second wave submissions, Modules 2 to 5 as per defined timelines.
- Evaluates proposed changes and provides on time regulatory input for worldwide regulatory impact.
- Contributes to performance and KPI´s of the team to deliver agreed targets and objectives and supports reporting.
- On time response to HA commitments and deficiency letters.
- Ensures that the escalation process to next or higher-level management is followed, as applicable.
- Ensures the receipt of proper product transfers from DRCs, MRCs and BD Regulatory.
- Ensures proper data management and completion of all assigned trainings within specified timelines.
- Any other responsibility assigned after training (as applicable).
Minimum Requirements
- Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology, or equivalent) – Masters or Bachelors
- Good written and spoken English. Knowledge of local language is an advantage.
- 2-4 years of relevant experience in regulatory affairs, preferably in a global organization in generics.
- Fresh campus graduates with high learning agility can also be considered.
- Exposure to project management is a plus
- Well-structured, result-oriented, highly self-committed, resilient, flexible, and a team player
- Strong orientation towards operational excellence
Work Location: Hyderabad, AP, India
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