Submission Manager – Global Regulatory Affairs
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Ballerup
If you would like to work with a dedicated team of submission managers on global submissions, this is a great opportunity.
In Submission Management we are looking for a permanent submission manager to help manage and facilitate global regulatory submissions to ensure deliverables for a given portfolio. You will join a team of dedicated and skilled submission managers responsible for ensuring compliant and timely global submissions across all portfolios. We are based in Ballerup, Denmark, in Dublin, Ireland and in Madison, NJ USA.
The job
This position is overall accountable and responsible for project managing compilation and publishing of global submissions, as well as maintaining the overview of all submissions to ensure deliverables across a given portfolios.
As a Submission Manager in Global Regulatory Affairs at LEO Pharma A/S, your responsibilities include:
- Act as Project Manager of tasks related to compilation and publishing of 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, 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)
- 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)
- 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
In addition, you will continuously provide feedback and new ideas on improving the submission process and take part in improvement activities. You will be based at our office in Ballerup, Denmark. Some travel may be required.
Your qualifications
- BA/BSc Degree in scientific discipline required; Master’s Degree preferred
- 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 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
- 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
You will have solid project management and presentation skills, be an excellent communicator with the ability to collaborate well with a large number of stakeholders, with an understanding of cultural differences and perspectives. You will have a strong drive and ability to execute according to plans as well as a continuous improvement mindset.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 6.9.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Ballerup
- Mandag den 27. september 2021
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