We use cookies. Find out about cookies here. By continuing to browse this site you are agreeing to our use of cookies.

Director, Regulatory Affairs Lead - United States, Madison, New Jersey

Created 04/16/2021
Reference oAe8efwU
Category Compliance Officers
Job type Full Time
Country United States
State New Jersey
City Madison
Zip Not specified
Salary Competitive
Description

Create and drive the regional regulatory strategy for a product / project and ensure there is a sound regulatory foundation for the successful optimization of the product /project in accordance with business priorities working closely with local RA and/or regional cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global strategy via the GRT.

  • Primary RA representative and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required).
  • Responsible for the regional regulatory strategy by liaising with local RA to ensure alignment with regional and global commercial plans and priorities to optimize portfolio.
  • Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts 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.
  • 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.
  • Maintain 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, interpretation by applying 'out of the box thinking' mind set, direction to GRT, GPT/LCM teams (as relevant) and region of responsibility.
  • Act pro-actively and sustain a 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.


Required Experience:
  • Master or degree within natural science or equivalent.
  • Seniority within regulatory +5 years, with primary responsibility of having achieved major local regulatory milestones, including drug development milestones (e.g., pre-IND, National Advice) and/or life cycle management milestones (e.g., line extensions).
  • Broad business understanding and knowing the business and the impact of the project.
  • Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions/filings/label.
  • Understanding of science and data relevant for development and LCM.
  • Expert regional regulatory guideline, requirements and precedence to inform strategic regional considerations.
  • Regional business acumen.


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
We want you to be yourself. We hire the best, give outstanding training and set you free. If you're driven to perform, you'll fit right in. We approach our work daringly, learn quickly, improve constantly, and celebrate our wins at every turn. Everyone is welcome- as an inclusive work environment, our employees are comfortable bringing their authentic whole selves to work.

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 [email protected] .

#LI-RP1