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Global Regulatory Submission Manager

Posted 14 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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REQ-10011623

Jun 14, 2024

United Kingdom

Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.   To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role: This role offers hybrid working, requiring 3 days per week in our White City, London office. As Global Regulatory Submission Manager you will be responsible for managing the delivery of cross functional submission documentation, overseeing publishing activities and the dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.

About the Role

Major accountabilities:

You will manage multiple and simultaneous global regulatory submissions projects in eCTD and non-eCTD formats,

You will driveand ensure timely delivery of submission components by supporting cross functional teams.

You will provide guidance to project teams on worldwide HA submission requirements, filing strategy, document lifecycle management and compilation workflows, tracking timely delivery, reviews and approvals.

You partner across functions, troubleshoot submission technical / quality issues and manage the efficient use of resources.

You will organize, lead and facilitate/ participate in both internal and external stakeholder meetings.

Your Experience:

Bachelor's degree in life sciences or relevant discipline.

Regulatory affairs or regulatory submissions related experience in global regulatory formats and submissions publishing activities.

Familiarity with the drug development process, global HA regulations/ guidance e.g. FDA, ICH, EMA.

Strong interpersonal skills and experience working in a complex, cross functional organization.

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

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

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

Development

Pharmaceuticals

United Kingdom

London (The Westworks)

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Research & Development

Full time

Regular

No

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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

REQ-10011623

Global Regulatory Submission Manager

Apply to Job

Research & Development Development United Kingdom

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