Novartis Latest Life Science Job Openings – Regulatory Affairs Post
Novartis Latest Life Science Job Openings – Regulatory Affairs Post. BSc and MSc Life Science candidates apply online for a Senior Executive, Regulatory Affairs (API) position that is available at Novartis. Novartis is hiring bsc/msc candidates, as per the details below in their Research & Development area:
Your responsibilities consist of but not limited to:
To assist in timely submission of new DMF submissions and DMF amendments for the required regions EU, US, CN, ROW etc) to finalize deficiency responses in time and provide regulatory support to contribute to global API regulatory submissions and strategies.
Prepare CMC responses to health authority questions during development, registration and product lifecycle. Assuring technological congruency and regulatory compliance and meeting agreed-upon timelines throughout the project lifecycle.
Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that might impact submission quality or timelines, as early as possible. Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents based on project timelines.
Proactively participate as a member of the global Regulatory CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with partners and customers.
Regulatory assessment of change control proposal received from manufacturing sites. Evaluation of DMF from external API distributor in line with HA requirements and according to established procedures. Regulatory Evaluation and Risk Management of Potential Mutagenic Impurities in Externally Sourced and Internally Manufactured APIs or API changes
Upkeep of various lists/documents submission records, communications, DMF submission records.
Keep knowledge approximately date with regard to regulatory guidelines and requirements in all global regions as well as for new technological trends.
Minimum requirements:
University or College Degree in any kind of field or life science with relevant industry experience or comparable degree
Minimum 4-6 years’ experience in the Pharmaceutical area, specifically in Regulatory Affairs in API is preferred.
Organizational awareness and experience working cross-functionally and in global teams is a plus.
Ability to work under pressure, demonstrating initiative and versatility
High level understanding of Regulatory quality, standards and policies.
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