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Associate Regulatory Submissions Manager

Quality & Laboratory
Danielle Francois
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Job Reference: JO-2103-65677_1616096892


My client is one of the leading companies helping patients globally with debilitating skin conditions. They are consistently working to understand patients needs and pioneering new products to treat them. Due to continued growth and evolution within the company, a role has come up for an Associate Regulatory Submissions Manager to join the dynamic global team based in Dublin but working with stakeholders worldwide.

This is an excellent opportunity to join a growing team that is invested in learning and development and working to build your career in Regulatory Affairs.

Day to day you can expect to

· Be involved in the project management that goes along with publishing global regulatory submissions such as creating timelines for submissions, managing time delivery of compliant global submissions, supporting the Submission Manager in the leadership of the global regulatory team,

· Take ownership of technical interactions with global HA, gateways, validations etc.

· Be Responsible for ensuring processes related to eCTD readiness and authoring submission documentation are adhered to

· Provide feedback and input in process improvement for submissions management

A little about you

· You will be an excellent communicator with ambition and drive and be looking for an environment where you can learn and grow.

· You will have a scientific education and possess a BA / BSc if you have an MSc or MA that would a great benefit but it's not a prerequisite for applying to this role

· Interest and experience in project management, well-developed PM skills

· A background in regulatory affairs is not essential but a deep interest in this area is a must-have.

· Awareness of global HA requirements in relation to dossier management and submission processes

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Danielle Francois
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