Senior Submission Manager – Global Regulatory Affairs
On behalf of my client we are accepting candidates for the role of Senior Submission Manager to work within the Regulatoy Affairs Submission Management Department based in Dublin. This role will directly report to the Head of Regulatory Submission Management.
Your role will help them set the direction for the department going forward, manage and facilitate complex regulatory submissions and also mentor and train less experienced colleagues, to ensure deliverables across many portfolios. You will join a team of dedicated and skilled submission mangers responsible for ensuring compliant and timely global submissions across all portfolios.
The primary tasks of the role include (but are not limited to):
This position is overall accountable and responsible for project managing compilation and publishing of complex submissions, as well as maintaining the overview of all submissions under a portfolio. while mentoring and training less experienced colleagues, to ensure deliverables across many portfolios.
As a Senior Submission Manager your responsibilities include:
- Acting as Project Manager of tasks related to compilation and publishing of complex global Regulatory submission
- Creating and 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
- 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.
- Responsible 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
The ideal candidate will possess the following:
Professional competencies & Business Insights
- BA/BSc Degree in scientific discipline required; Master’s Degree preferred
- 3+ years’ experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA)
- Experience working within a Submission Management function, managing complex global submissions with in-depth knowledge of global regulatory requirements for major markets US, EU, JP, CN, CA and RoW
- Strong command of the English language is essential
- Solid understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
- Solid knowledge and experience within Submission Management and global market/HA requirements in relation to dossier management and submission processes
- The ability and willingness to travel internationally (mainly Europe) approximately 10-15%
For full details contact Ciara at +353 1 2784671 or email your CV to email@example.com Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com