GRSB-0, Associate- Regulatory Submission Management

Work Your Magic with us! 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Description:

• Publish and produce dossiers using Extedo’s eCTD Manager and Veeva Vault, perform quality checks and dispatch dossiers. 

• Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle. 

• Create and update submission packages and Submission Content Plans for submissions to Health Authorities. 

• Create and update entries in Regulatory Information Management system and ensure submissions are documented properly in regulatory systems (RIMS, Veeva Vault RIM). 

• Liaise with R&D functions to provide required submission-relevant documents on time and in submission ready format. 

• Key contact for eCTD and Publishing expertise. 

• Act as power-user for submission applications (RIM, eDMS, eSM). 

• Author cover letter and application forms for eCTD lifecycle submissions in close cooperation with the TA responsible. 

• Monitor compliance with submission standards and submission process (internal & external). 

• Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements. 
   

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!