Senior Submission Manager – Global Regulatory Affairs
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Ballerup
If you would like to help shape the submission management department of the future and mentor more junior colleagues, this is a great opportunity.
In Submission Management we are looking for a senior submission manager to help us 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. 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 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 in Global Regulatory Affairs at LEO Pharma A/S, your responsibilities include:
In addition, you will work with the head of Submission Management and other Senior Submission Managers, sharing your ideas to ensure efficient running of the department to create a happy high performing team. As well as providing input to a development programme to ensure we grow and develop our talented team. You will be based at our office in Ballerup, Denmark. Some travel may be required.
Your qualifications
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 and 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 flair for mentoring colleagues, and sharing new ideas.
Contact and application
If you have questions, please do not hesitate to contact Sinead Whelehan, Senior Manager, Submission Management, Global Regulatory Affairs, at [email protected] or +353 87 4175211.
. The deadline is 18th April 2021.
In Submission Management we are looking for a senior submission manager to help us 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. 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 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 in Global Regulatory Affairs at LEO Pharma A/S, your responsibilities include:
- Act 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.
- 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 defining and governing processes related to eCTD readiness and authoring submission documentation (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 work with the head of Submission Management and other Senior Submission Managers, sharing your ideas to ensure efficient running of the department to create a happy high performing team. As well as providing input to a development programme to ensure we grow and develop our talented team. 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
- 8+ years’ experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA)
- 5+ 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
- 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
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 and 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 flair for mentoring colleagues, and sharing new ideas.
Contact and application
If you have questions, please do not hesitate to contact Sinead Whelehan, Senior Manager, Submission Management, Global Regulatory Affairs, at [email protected] or +353 87 4175211.
. The deadline is 18th April 2021.
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 6.4.2021, 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
- Søndag den 18. april 2021
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