Regulatory Submission Management Specialist

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.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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Regulatory Submission Management Specialist

Your Role

Manage and provide follow-up on the preparation and documentation of regulatory dossiers for submission to Health Authorities worldwide. Ensure compliance with Health Authority requirements, functional SOPs, and other internal guidance. Streamline submission processing by guiding and harmonizing across functional area.

Your Responsibilities

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 Veeva Vault RIM and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details. Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format. Publish and 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 regulatory systems (Veeva Vault RIM). Able to author cover letter and application forms in close cooperation with the License Manager or Country Regulatory Affairs. 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.

Who you are

• Degree in a Life Science or related discipline
• 1 to 4 years of experience in Regulatory Affairs or Regulatory Operations
• Excellent spoken and written English
• Project management skills, international project experience desire.
• Excellent organizational skills, work independently, self-motivated and proactive.
• Goal-oriented and pragmatic approach to work
• Attention to details.
• Excellent communication and interactive skills.
• Excellent interpersonal skills.

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!