Associate Director, Regulatory Affairs

Location
Lake Forest, IL, United States
Posted
Nov 12, 2020
Ref
R0002143
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

This position is responsible for the regulatory support of products marketed in the U.S., E.U., and rest-of-the-world (ROW) as well as development stage products. This position is also responsible for coordinating all aspects of regulatory submissions for assigned projects, providing guidance on post-approval changes, developing regulatory strategy, and representing the function on cross-functional teams.

Responsibilities:
  • Develop and implement regulatory strategies for investigational and commercial drug products
  • Provide required regulatory documentation for IND/ IMPD/NDA/BLA/MAA submissions and subsequent variations/supplements.
  • Provide guidance on the content and suitability of regulatory documents for submission
  • Provide input into the response strategy to health authority comments and questions
  • Participate in regulatory agency inspections, as required
  • Keep abreast of industry trends with respect to regulatory policies and procedures within the EU, US, and ROW
  • Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOP's
  • Cultivates relationships with key colleagues in other parts of the organization, in the industry and in the profession
  • Mentors, develops, and assesses direct reports including monitoring and managing workload and assignments


Qualifications and Skills Required:
  • Minimum BA/BS in related scientific discipline (biology, chemistry, biochemistry, immunology, pharmacy)
  • Significant experience (10+ years) in the pharmaceutical industry with the majority of that time having been in regulatory roles handling both strategic and tactical aspects of the work.
  • Preferred knowledge and experience with the regulatory process for approval of both biologics and small molecule products
  • Demonstrated ability to work and draft documents in a fast-paced environment
  • Flexible with respect to prioritization of daily tasks and projects according to internal and external influences
  • Strong organizational skills and attention to detail
  • Excellent written and verbal communication skills


Horizon Core Values & Competencies:

Growth
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent


Accountability
  • Drives Results
  • Ensures Accountability
  • Decision Quality


Transparency
  • Courage
  • Collaboration
  • Instills Trust


Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.