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Specialist - Regulatory Submission Management
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Job Description - Specialist Regulatory Submission Management
Purpose of the 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.
Main interfaces: (ranked by order of importance):
- Regulatory Project Manager
- Country Regulatory Affairs (Regional Hubs/REC)
- Global Regulatory Lead
- Global Clinical Operations
- Global Patient Safety
- R&D Informatics
- Other Global Regulatory Affairs functions
- Functions that contribute to Module 3 on Chemical, Manufacturing and Controls
- Clinical functions
- Non-clinical functions
Key tasks and 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 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.
- Degree in a Life Science or related discipline
- 3-4 years’ experience in Regulatory Affairs or Regulatory Operations.
- Excellent spoken and written English.
Professional skills and experience:
- Minimum 2 years’ experience in submission management or publishing in eCTD, NeeS and paper format.
- Proven ability to handle regulatory applications needed to support the regulatory function according to the role.
- Strong project management skills, international project experience.
- Excellent organizational skills, work independently, self-motivated and proactive.
- Goal-oriented and pragmatic approach to work.
Personal skills and competencies:
- Attention to details.
- Excellent communication and interactive skills.
- Excellent interpersonal skills.
- Strong team player with ability to work with multidisciplinary teams within a matrix and in an international environment.
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!