Regulatory Senior Submissions Manager
Our client, a global pharmaceutical company, are currently recruiting for a Regulatory Senior Submission Manager.
- Will be part of the Regulatory Submission Management Department, supporting a variety of key areas onsite. Working across cross-functional teams with a high-level of autonomy.
- This position will report into the Regulatory Submission Management Team Lead.
- As a Submission Manager your overall objective is to plan, manage and facilitate the delivery of submissions within a given product/portfolio. This position is the overall accountable and responsible for project managing individual submissions under an asset, from planning through to case closure. This position involves close collaboration with companys global submission sourcing partner.
Key Responsibilities include
- Preparation of the Regulatory Submission Pipeline
- Ensuring the creation and project management of Regulatory Submission Plan for individual submissions
- Providing advice on submission approach and HA requirements as well as ePublishing requirements to relevant project members and content owners
- Preparation, review, coordination and follow up (depending on submission type) to secure relevant documents and submission components for the dossier
- Ensuring proactive follow up on submission status/approval timelines making sure progress is managed till HA approval and case closure
- Communicate key milestones to relevant stakeholders
- Providing feedback/new ideas for improving the submission process and the sourcing set-up and take part in specific improvement activities
- Providing support/guidance to company sourcing partner giving advice and answering questions on specific tasks within the Regulatory Submission Pipeline, as needed
- Representing Submission Management in the Regulatory focus teams within a given portfolio/product Providing overview/status of submission activities relevant to the team and presenting and highlighting the submission strategy and relevant submission intelligence/approach, risks and solutions when needed.
- 5 7 years of experience working within Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar)
- Solid knowledge and experience within Submission management and the different market/HA requirements in relation to dossier and submission process
- Solid understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
- Attended training/courses within Regulatory Affairs and project management
- Good or solid knowledge on Pharma and interfacing areas to Submission Management
- Strong and solid project manager skills (especially solid communication, collaboration and presentation skills as well as planning and delegation skills; strong ability to manage a submission pipeline, keep the overview and prioritise
- Timely, fast and quality focused when executing submissions
- Knowledge and experience interacting with different stakeholders with the understanding of cultural differences.
For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671