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Senior Director, Global Regulatory Lead

Company: LEO Pharma, Inc
Location: Madison
Posted on: September 14, 2020

Job Description:

Senior Director Global Program Management Jobs in Madison, NJ. Thank you for your interest in the Senior Director, Global Regulatory Lead opportunity based in Madison, N.J.. *Please note: due to Covid-19 this position may start remotely and later transition on-site to Madison, N.J.. At LEO Pharma, we seek passionate, entrepreneurial and solutions-oriented colleagues, and consistently ensure that our people can proactively develop their capabilities and fulfill their potential. Together, we can embrace the changing healthcare landscape and grasp strategic business opportunities. The result: life-enhancing products that bring hope to patients living with chronic dermatologic diseases.. What the Senior Director, Global Regulatory Lead will fulfill:. The Senior Director, Global Regulatory Lead is overall accountable for global regulatory strategies and deliverables to development and life cycle management activities in collaboration and alignment with but not limited to other functions, such as e.g. R&D, Commercial, Market access and GPS for 1 highly complex asset or multiple assets with less complexity.. Your contribution to the team includes:. Strategic lead of the GRT (Global Regulatory Team) and overall accountable for creating the global regulatory strategies for assigned product(s), and secure GRS are updated on an ongoing basis. Ensure there is a sound regulatory foundation with identified risks and mitigation for the success-ful optimization of their product(s) to secure the optimal approval / maintenance to maximization opportunities.. Define regulatory strategic direction, review and provide critical regula-tory input into documents that will be included in regulatory applications and interactions, as applicable.. Lead a team of dedicated EU/US leads and Regulatory Professionals, as allocated.. Drive the global regulatory strategy for a product(s), regulatory interac-tions, submissions and approvals, with global strategic accountability while leveraging their GRT subject matter experts.. Responsible for having full overview of activities within the GRT. Account-able for securing coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs, MAV/sNDA).. Maintain expert knowledge on regulatory environment in FDA/EMA/key international markets and ICH guidelines including competitive intelli-gence/landscape.. Provide clear, ‘out of the box thinking’ but valid regulatory guidance by leveraging on all input and set direction to GRT and asset teams (ie LCM/GPT). Act pro-actively and sustain good stakeholder collaboration within GRA and in LEO organization via continuous stakeholder manage-ment.. Proactively propose and recommend a fit-for-purpose adjustment of the GRT setup (both adding and reducing members and establishment of RA Working groups) when relevant and obtain approval with GRALT.. Contribute to the development and training of RA persons with regards to Global Regulatory Strategies.. Empowered to prioritize regulatory activities for assigned asset(s) in ac-cordance with LEO governance.. Act as people manager for a team of dedicated EU/US leads and Regu-latory Professionals, as allocated.. Represents GRA to asset teams (i.e., LCMteam (Established)or Global Program Team (Innovative).. Allocate budgets within predefined portfolio.. Responsible for demonstrating LEO Pharma leadership behaviors towards own team members and in the GRTs.. 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.. Key Working Relationships:. All members of the Global Regulatory Team, Relevant R&D functions, LCM, GPS, GQA and Commercial; US FDA and EMA.. Required Experience:. Master’s or Bachelor’s degree within natural science or equivalent. Advanced degree preferred.. >10 years pharmaceutical industry and relevant increasing global strategic regulatory experience.. Master’s Degree required.. Solid experience of the regulatory framework on a global level from both development- and life cycle management phases of drug development.. Managerial and leadership experience of 5 years preferred.. Broad business understanding and knowing the business and the impact of the project.. Strategic mindset with a curious and alternative mindset.. Proactive thinking and a ‘yes-can-do’ attitude.. Communication/sharing information to secure ‘one GRA voice’.. Personal drive, positive attitude and high level of commitment.. Think locally act globally; think globally act locally.. 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.. Perks. 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!. EEOC. LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.. 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.. #LI-PA1. Get alerts to jobs like this, to your inbox.

Keywords: LEO Pharma, Inc, Madison , Senior Director, Global Regulatory Lead, Other , Madison, Wisconsin

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