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Regulatory Submissions Manager

Quality & Laboratory
Danielle Francois
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Job Reference: JO-2103-65678_1616141427


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 a Regulatory Submissions Manager for a 12-month temporary contract working with the dynamic global team based in Dublin but working with stakeholders worldwide.

· Act as Project Manager of tasks related to compilation and publishing of global Regulatory submission, managing cross-functional timelines for global submissions with consideration of key interdependencies

· Leading a global (external) publishing team in the context of a given submission & managing the timely delivery of compliant global submissions and be responsible for technical interactions with global HA, i.e. gateways, validation issues and similar

· Submission Manager lead of Global Regulatory Team - Providing overview/status of submission activities relevant to the team and presenting and highlighting the dossier strategy and relevant submission intelligence/approach, risks and solutions as relevant, under the guidance of senior colleagues as required.

· Standardizing best practices for management of regulatory submissions to ensure consistency (e.g. defining submission process and timelines, adopting global core dossier and abbreviated dossiers concept and principles) and provide feedback and new ideas on improving the submission process and take part in improvement activities.

· Responsible for ensuring processes related to eCTD readiness and authoring submission documentation are adhered to (in close collaboration with Regulatory System and Data Management Dept) and for intelligence related to eCTD readiness and GxP, Good Documentation practices

· Responsible for end-user liaison and advocacy within and outside of GRA, as required for document management

A little about you

· Professional competencies & Business Insights

· BA/BSc Degree in a scientific discipline required; Master's Degree preferred

· Experience in both US and global submissions beneficial

· 5+ years' experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA)

· 3+ years' experience working within a Submission Management function, managing global submissions with knowledge of global regulatory requirements for major markets US, EU, JP, CN, CA and RoW

· Understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities

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
Danielle Francois
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