Detail

Salary
negotiable
Location
Madison, New Jersey, USA
Posted by: Leo Pharma
01 May
15 Views
30 Jun expires

Manager, Regulatory Strategy, Madison, New Jersey

Madison, New Jersey, USA
Job Description

Support the regional regulatory strategy for a product(s) as assigned and ensure there is a sound regulatory foundation for the successful optimization of the product(s) in accordance with business priorities working close with local RA and EU/US commercial colleagues where required to ensure alignment on global strategy via the GRT 

  • May be the primary RA regional representative or support to regional lead and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local EU+ RA where required).
  • Provide support for the regional regulatory strategy and work with commercial plans and priorities to help optimize portfolio.
  • Where delegated, secure regulatory interactions, and ensure submissions, with strategic support accountability for the regional filings while leveraging their GRT subject matter experts and other functions where needed and endorsed by GRT.
  • Review relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance / legislation, as applicable, while leveraging GRT subject matter expertise.
  • In conjunction with the regional lead or global lead, manage coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines.
  • Grow expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including Competitor intelligence/landscape.
  • Provide clear and valid regulatory guidance, direction to GRT and region of responsibility and learning what options could be possible.
  • Act pro-actively and sustain good stakeholder collaboration within GRA and in LEO organization via continuous stakeholder management.
  • Represent GRA according to delegated tasks.
  • Provide budget input for regions plans.
  • 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.
Job ID Reference
1503
Desired Skills & Experience
  • Master's or bachelor's degree within natural science or equivalent. Advanced degree preferred. 
  • Seniority within regulatory +3 years, within different kind of regulatory activities.
  • Some experience of the regulatory framework on a regional level from development- and/or life cycle management phases of drug development.
  • Demonstrated general regional regulatory requirements. 
  • Exhibits ability to interpret guidelines and give recommendations for day to day regulatory strategic activities. 
  • Broad business understanding.
  • 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.
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation.
Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 Madison, New Jersey, USA