Associate- Regulatory Submission Support

3 days ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

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.

**Title: Associate - Regulatory Submission Support**

**Location - Bangalore**

**Responsible for daily deliverables**:

- Collaborating with Authors/ GRL/ SMRA/ PMRA for document readiness activity.
- Formatting of documents for all disciplines contributing to Regulatory Dossiers and all products
- Creating and updating Virtual Documents. Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness of submission relevant documents.
- Supporting stakeholders with required literature via ordering at Scientific Library, formatting, uploading, approving.
- Report publishing for all safety reports, clinical safety management plans as well as nonclinical reports via publishing tool.
- Point of contact for supporting all stakeholders in eDMS related questions.
- Being able to independently resolve routine and complex issues with mínimal guidance.
- Assuring that submission documentation meets registration needs and timelines.
- Managing lifecycle of the documents
- Manage and maintain templates in the VEEVA system. Prepare the submission readiness in VEEVA system.
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**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

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