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Associate Director, Regulatory Affairs Submission Management, Madison, New Jersey

Created 01/12/2021
Reference oBWfefwK
Category Compliance Officers
Job type Full Time
Country United States
State New Jersey
City Madison
Zip Not specified
Salary Competitive

As we continue to grow, we are seeking an Associate Director, Regulatory Affairs Submission Management lead of the Global Regulatory Team to manage and facilitate the delivery of submissions within a given product/portfolio. This position is a global position, overall accountable and responsible for project managing compilation and publishing of individual submissions under a portfolio.

For "development projects" (e.g. NDA/MAA with new scientific content, INDs and/or other projects considered relevant for LEO to manage in-house) the Associate Director is responsible for monitoring progress and performance (via the eCTD tracker and/or project plans) and for securing deliverables to the individual submissions. This is done in close collaboration with RA project responsible, RA content owners, contributing functions outside of RA and Local RA.

For "maintenance/lifecycle projects" (e.g. CMC/Labelling variations, renewals, AgSRs/PSURs, withdrawals and similar) the Associate Director is responsible for monitoring progress performance via the project plans/ eCTD tracker and for securing deliverables for the individual submissions. This is done in close collaboration with LEOs sourcing partner, RA project responsible, RA content owners, contributing functions outside of RA and Local RA.
Mentor and train less experienced colleagues.

  • Act as PM 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.
  • 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 etc.)
  • 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
  • Responsible for handling deviations relating to documentation practices within the scope of GRA
  • Training, coaching and mentoring less experienced colleagues and those new to GRA to learn the basics of RA, i.e. RA tasks, registration procedure, business insight etc.
  • Providing feedback/new ideas for improving the submission process and taking part in specific improvement activities.
  • Additional duties as assigned by LEO Pharma Management.
  • Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.
Required Experience:

Professional competencies & Business Insights
  • BA/BS Degree in scientific discipline required; Master's Degree preferred
  • Experience in both US and global submissions
  • 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
  • Solid understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
  • Solid knowledge and experience within Submission management and the different market/HA requirements in relation to dossier management and submission process
  • Strong and solid project management skills, solid communication, collaboration and presentation skills as well as planning skills; strong ability to manage a submission pipeline, compilation and publishing of complex global submissions; ability to keep the overview and prioritize; strong drive and ability to execute according to plan, create and manage cross functional timelines and collaboration with relevant stakeholders
  • Timely, fast and quality focused when executing on submissions; focused on KPIs and timeline driven
  • Knowledge and experience interacting with different people (e.g. Local RA, publishing team etc.) also with the understanding of cultural differences and perspectives
  • The ability and willingness to travel internationally (mainly Europe) approximately 10-15%
  • Experience with mentoring and developing colleagues with varying levels of experience
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation

Ready to learn more about LEO Pharma?
LEO Pharma has been pioneering medical innovations for more than 110 years. Today, LEO Pharma looks to constantly improve and extend what is possible for the benefit of patients. Our rapidly expanding product portfolio and pipeline includes global therapeutic areas in psoriasis, eczema, skin infections, acne, rosacea and, most recently, rare disease.

LEO Pharma believes in challenging the status quo, so we approach dermatology "beyond the skin." Our global innovation ecosystem includes internal research and development, digital health via the LEO Innovation Lab, based in Copenhagen, and the LEO Science & Tech Hub, housed in Cambridge, Mass.

As we look to shape our U.S. footprint now and in the future, we pride ourselves on our agile and entrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.

We offer a competitive compensation package, 401k match, vision, dental and health insurance, annual bonus, three weeks' vacation to start, a culture that emphasizes work-life balance, both paternity and maternity leave, free membership to the on-site gym, bagel Monday's and - most of all - a FUN and celebratory work environment.

Let's wrap this up
If you are interested in joining a growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!

A diverse workforce fosters innovation and strengthens Leo Pharma's mission. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Thank you for your interest in career opportunities at LEO Pharma Inc.

Please note:
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels: the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com" screening and interaction by telephone and through the Microsoft Teams platform.

LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.

Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.

LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.

If you have any questions about LEO Pharma Inc. and the application process, please email the company's U.S. People and Communications team at HRUS@leo-pharma.com.