Regulatory Affairs RWE LEAD
1 month ago
Do you want to join our team at Novo Nordisk and dive into the dynamic world of Regulatory Affairs? With a patient focus, deep scientific understanding, and expertise in managing diverse stakeholder interests, every day with us is rewarding and intellectually enriching.
If you thrive driving several projects and initiatives across functions, we invite you to read more and apply to join our RWE & RA SEMA CVOT team in Søborg/Copenhagen.
The position
As a RA RWE Lead, you will leverage learnings and strategic approaches of integrating RWD/E in development projects, regulatory decision-making, and labelling. As our new RA RWE Lead, you will represent global regulatory affairs (GRA) in various projects and external platforms to shape the Real World Data/Evidence (RWD/E) landscape for regulatory decisions.
Your main responsibilities will include: Plan and conduct of regulatory RWD/E and Semaglutide Outcome Trials’ interactions with health authorities Support projects to prepare and submit of regulatory RWD/E related files and response to questions from health authorities Be responsible for providing regulatory inputs to RWD/E Guidance Documents and RWD/E Interactions with Health Authorities Provide training and share lessons learned and best practice across GRA
Qualifications
We are looking for someone that has solid knowledge in regulatory science, clinical development, data generation, medical and disease area understanding. You can interpret clinical data and build strong regulatory science strategies and submission scenarios.
To succeed in this role, you will have:
Educational background as MD, PharmD, MSc, or PhD Extensive experience working with real world evidence, clinical trials or regulatory affairs Demonstrated experience as a project manager Strong stakeholder management and networking skills Fluent in written and spoken EnglishAs a person, you demonstrate proactive leadership style and act with a committed, persistent and accountable behaviour. Your strong change management skills, as well as planning and coordination skills, help you to identify problems and solutions proactively – keeping things simple and eliminate unnecessary complexity.
About the department
RA SEMA is responsible for defining and driving regulatory strategies for our semaglutide & cagrisema projects in all phases of development. We are dedicated and highly engaged employees work as an integrated part of the global development and research projects and play a key role in cross-functional teams. We are responsible for the semaglutide and cagrisema regulatory strategy and provide regulatory expertise and tactics to product development plans. We drive label development, health authority interactions, and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
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