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GRCD-0, Specialist Regulatory CMC
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.
This Role will be fully dedicated on CMC regulatory intelligence team activities, aiming to enhance the GRA CMC knowledge sharing culture, with a specific focus on the following:
- Support the End to End updating process of the ATO database consisting amongst others:
- To perform a review of the Health Authority question/ Heath Auth Interactions to assess primarily the CMC impact (e.g. CMC sections of the dossier and assigned CMC topics..) and also, as applicable, on CMC-related aspects contained in labeling, safety, clinical, administrative docs.
- To provide and/or liaise with GRA CMC experts product specialist to analyze and interpret key learnings,
- To ensure proper integration between Veeva and APEX/Spotfire (data cleaning etc…)
- when needed, to coordinate regular and ad-hoc related updates to the internal regulatory CMC requirements data bases (Wikihandbook, RCR Catalogue)
- And to communicate such learning throughout “Knowledge sharing sessions” and “Annual Report including statistics and trend analysis”.
And to provide any other ad-hoc support on activities executed by RI, envisaging to (Rq. such resp. can be subject of specific training and development path):
- Perform Surveillance and Sharing of Global CMC Related Regulatory Requirements
- Provide support on specific RI project
- Ensure Company One Voice Internally and Externally
- Support Scientific and CMC Reg Advice
Enable the centralized and harmonized way of working by building and maintaining high-quality in-company regulatory requirement data base and execute focused intelligence searches
Support the continuous improvement by applying learnings and executing continuous regulatory requirements data base updates.
Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of RI tasks/activities, under close supervision and guidance provided from the RI and/or Local CMC Managers and join collaboration.
Internally: Global Regulatory Affairs (including Regional and Country regulatory departments) Other Healthcare Global and Local Manufacturing functions (e.g. GHO/HCQ…)
Externally: External Partners and service providers
Graduate or Post Graduate in a Life Science or a related discipline.
CMC Regulatory Experience and knowledge of eCTD (from 2 to 7 years) with Pre- Marketing and/or Post-Marketing Authorization activities for Chemicals and/or Biologicals.
Experience in IT systems preferable with some exposure to Veeva Vault.
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!
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