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Global Program Regulatory Manager - Life Cycle Management

Posted 9 Jul 2024
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Work experience
0 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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Major accountabilities: Regulatory Strategy Provide input to global program regulatory strategy, including regulatory designations & innovative approaches. Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables. Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for HA interactions. May facilitate HA meetings or act as local HA liaison respectively. Regulatory Submissions Leads planning, preparation and submission of clinic trails, and the implementation of defined global registration strategy into regional submissions worldwide with country organsiations. Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned. Lead regulatory activities during HA reviews, responding to questions and HA interactions. Regulatory Excellence & Compliance Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems. Life Cycle Management You may also focus on one of the following key areas of activity: Maintenance – preparation of selected global regulatory submissions. Portfolio Transformation – e.g. streamlining activities, divestment/ integration, portfolio transformation and manufacturing transfer. Business & Operational Excellence – collating, for example, registration samples, CPPs etc. to support submissions. Your Experience: Science based bachelors degree, plus an understanding of pharmaceutical development, clinical trials. Track record of involvement in regulatory or pharmaceutical development, in one or more major regions. Strong interpersonal skills and experience working in a complex, cross functional organization and leading cross function teams. Compliance and Quality mindset. Fluency in English. 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? : https://www.novartis.com/about/strategy/people-and-culture 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: https://talentnetwork.novartis.com/network

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.

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