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Associate Director, Global Regulatory Submission Management

Posted 14 Jul 2024
Work experience
0 to 7 years
Full-time / part-time
Job function
Degree level
Required language
English (Fluent)

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Major accountabilities: Manages multiple, large and complex global regulatory submission projects in eCTD and non-eCTD [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.] efficiently, accurately and simultaneously. Key contributor and decision driver in submission management activities related to acquisitions, partnerships and divestitures, point of contact for regulatory agency inspections, and other miscellaneous regulatory operational activities. Provides expert guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows. Lead, coach and mentor peers and colleagues. Develops and authors training materials and leads efforts to implement training to ensure optimal use of templates, processes, and tools critical related to regulatory submission activities. Expert advisor in evaluation, selection, and implementation of technologies and processes related to submission planning, publishing, assembly, and archiving (as needed). Submission Management Expert on key internal initiatives, Health Authority meetings and various industry forums/conferences, as required. Excellent ability to troubleshoot and assess technical/quality issues relating to compilation, validation and dispatch of global submission outputs with accuracy. Your Experience:  Bachelor’s degree in Life Sciences or a relevant discipline. Master’s degree preferred. Extensive experience and knowledge of the Regulatory Affairs environment, regulatory submission format and HA requirements and publishing processes. Extensive knowledge of drug development process, worldwide regulatory practices, electronic submission guidelines and requirements as well as publishing processes. Extensive experience with submission management related software/tools and the concepts required to produce worldwide regulatory submissions. Technically savvy. Strong interpersonal and negotiation skills, excellent communicator, and presenter. Extensive project management skills and experience leading meetings, cross functional teams and driving change. Must be able to innovate, analyze and solve problems effectively, accurately and independently. Fluent in English (both written & oral). Additional language an asset. Why Novartis:  Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? :    Commitment to Diversity & Inclusion:  Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.    Join our Novartis Network:   Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:  

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Active in 80 countries
300 employees
40% men - 60% women
Average age is 40 years