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Specialist - 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 unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
- 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 records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.
- Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.
- Validate eCTD output, perform quality checks and submit eCTDs through supported HA gateway
- Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output.
- Functional oversight of vendors for submission management and publishing.
- Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.
- Key contact for eCTD and Publishing expertise.
- Act as power-user for submission applications (Veeva Vault RIM).
- Author cover letter and application forms for eCTD lifecycle submissions in close cooperation with the Regulatory Lead.
- 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!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html