Novartis Biology Job – MSc & BSc Candidates Apply
Job Posting: Associate at Novartis
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
Sandoz, a division of Novartis, is expected to become a standalone organization in 2023. This presents an exciting opportunity to be part of a new and independent Sandoz. As an Associate, you will play a crucial role in implementing regulatory maintenance activities and second wave submissions to ensure the achievement of targets and business objectives. You will be responsible for preparing variations and second wave submissions, following established processes and timelines.
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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