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Senior Submission Manager - Global Regulatory Affairs, Dublin ...

Created 05/08/2021
Reference 78787
Category Compliance Officers
Job type Full Time
Country Ireland
City Dublin
Zip Not specified
Salary Competitive
SeniorSubmission Manager - Global Regulatory Affairs

A vacancy exists for a Temporary (12 month- maternity leave)SeniorSubmission Manager (P5)within theRegulatoryAffairs Submission Management Department based in LEOPharmaDublin. This role will directlyreport to theHead of Regulatory Submission Management.

Your role willhelp 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 manyportfolios..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 inBallerup, Denmark, in Dublin, Ireland and in Madison, NJ USA.

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 in Global Regulatory Affairs at LEO PharmaDublin, your responsibilities include:

  • Actingas 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


  • Leadinga global (external) publishing team in the context of a given submission


  • Managingthe timely delivery of compliant global submissions


  • Responsiblefor technical interactions with global HA, i.e. gateways, validation issues and similar


  • SubmissionManager 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,risksand solutions as relevant.


  • Standardizingbest 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 andGxP, Good Documentation practices


  • Responsiblefor 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 talentedteam .

The ideal candidate will possess the following:

Professional competencies & Business Insights

  • 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,CAandRoW
  • 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%


Behavioralcompetencies

• Drive Results

• Action Oriented

• Communicates Effectively

• Plans and Aligns

• Collaborates

You will have solid project management and presentation skills, be an excellent communicator with the ability to collaborate well witha large number ofstakeholders 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 mentoringcolleagues, andsharing new ideas.

About LEO Pharma

Our mission is to help people achieve healthy skin. We pioneer dermatology by looking beyond today to constantly improve and extend what's possible for the benefit of patients. We keep patients at the heart of everything we do.

We drive dermatology withour knowledge,collaborationand curiosity. We are at the forefront of science in developing new medicines for dermatology.As long asthere is a patient out there needing our help, we carry on our mission.

As a foundation - owned company we have the independence and obligation to put patients first. The collective skills and efforts from everyone at LEO Pharma and our partners are the basis for our success. Wecontinue onthe path we've charted for more than 110 years, building, sharing and reinvesting in knowledge. Because we care and because we can.

Let's pioneer together.

Closing date:21 May 2021

LEO PHARMA ISAN EQUAL OPPORTUNITIES EMPLOYER

All internal candidates must notify their direct manager if they apply for this role. Failure to do so, will result in you not being considered for this position.