Novartis Pharma Associate Manager Vacancy – Regulatory Affairs
Novartis Pharma Associate Manager Pharma Jobs. Applications are invited for the post of Regulatory Affairs @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job Title: Associate Manager – I, Regulatory Affairs, CMC
Job ID 299655BR
What you’ll bring to the role:
• Degree in Science (e.g. Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
• Experience of upto 4 years in regulatory and/or in the pharmaceutical industry preferred
• Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.
• Good oral and written communication skills with a collaborative and patient-focused mindset
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload
• Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
• Computer/IT systems literacy
Your responsibilities include but not are limited to:
• Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC).
• Activities such as the preparation 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 on CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements.
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
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