Novartis Biotech Regulatory Affairs Job – Biochem & Biology Apply
Novartis Biotech Regulatory Affairs Job – Biochem & Biology Apply. Biochemistry, Biotechnology, Biology candidates apply online for an Associate Manager – I, Regulatory Affairs, CMC position that is available at Novartis. Novartis is hiring MSc candidates, as per the details below in their Research & Development area:
Job Title: Associate Manager – I, Regulatory Affairs, CMC
Job ID: 299655BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: REG AFFAIRS GDD
Employment Type: Regular
Responsibilities:
Your responsibilities include however not are limited to:
- Responsible for regulatory activities specifically pertaining to chemistry, manufacturing, and control (CMC).
- Activities such as the prep work and publication of REG CMC documentation for submissions to Health Authorities. In addition, interact with HA’s on REG CMC questions to support new product or post marketed launches.
- Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle.
- Apply agreed with CMC global regulatory strategies, current regulatory trends and guidelines. Guarantee technical congruency and also regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
- Identify the required documentation as well as any kind of content, quality and/or timeliness issues for global submissions and also negotiate the delivery of approved technological source documents in accordance with project timelines.
- Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
- Actively participate as a member of the global RA CMC team by adding to the regulatory strategy, identifying the critical issues and also lessons learned.
- Perform activities in support of the general department such as data entry into the Regulatory Info Management System, other CMC database entry, or maintenance and operational activities as needed.
Minimum requirements:
What you’ll bring to the role:
- Degree in Science (e.g. Biochemistry, Biology, Biotechnology) or equal. Advanced Degree in Science desirable.
- Experience of up to 4 years in regulatory and/or in the pharmaceutical industry favoured.
- Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Capability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development procedure desirable.
- Excellent oral and written communication abilities with a collaborative as well as patient-focused mindset.
- Ability to work successfully with global project teams and also prioritize activities considering timelines as well as workload.
- Well-developed planning, organizational, negotiation, problem-solving and interpersonal abilities.
- Computer/IT systems literacy.
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