Associate Director, CMC Regulatory Affairs

Location
Lake Forest, IL, United States
Posted
Nov 12, 2020
Ref
R0002155
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.

The Associate Director of Regulatory Affairs/CMC Regulatory is responsible for managing both the strategic and operational aspects of Regulatory Affairs objectives for assigned commercial products, life cycle management initiatives and development candidates including global regulatory strategy, regulatory submissions, and interaction with regulatory authorities.

Responsibilities:

  • Provide regulatory leadership to cross-functional teams in the life cycle management of commercial products or development candidates and ensures cross-functional perspective is incorporated in regulatory strategies and plans
  • Primary liaison with Health Authorities for assigned commercial products or development candidates, and responsible for regulatory strategy, tactics and direction in the preparation of submission documents, responses to queries by regulatory authorities
  • Plan, lead, prepare, and manage CMC regulatory documentation for IND/ IMPD/NDA/BLA/MAA/NDS submissions and subsequent variations/supplements. This includes development candidates, post-market changes and routine annual updates
  • Review manufacturing/testing changes and provide regulatory impact assessments
  • Provide guidance on the content and suitability of regulatory documents for submission such as comparability, validation, and development reports
  • Prepare, review and deliver high-quality and timely filings for submissions, including adequacy/accuracy of the regulatory and scientific content and compliance with regulatory requirements
  • Contribute to developing and implementing a regulatory strategy and pathway which balance time, cost, quality and risk and meets the needs of Horizon, for development assets and new acquisitions
  • Provide interpretative analyses of new or complex regulatory guidance documents, regulations, or directives that impact Horizon's products and operations
  • Ensure quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs


Qualifications and Skills Required:
  • Bachelor's degree in Life Sciences, Chemistry or Biology. Advanced degree a plus.
  • 10 years previous biotechnology and/or pharmaceutical drug development experience.
  • 8 years regulatory affairs experience preferably involving direct contact with regulatory agencies; full knowledge of FDA, EU & ICH regulations and guidelines, and the ability to provide interpretations of the information to others.
  • Solid understanding of dossier requirements New Drug Application (NDA), Biologics License Application (BLA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA).
  • Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment.
  • Ability to strategically interpret and respond to requests from regulatory agencies.
  • Experience with effective project team leadership and management oversight.
  • Leadership capabilities working across varied cultures, expertise and backgrounds.
  • Strong interpersonal skills.
  • Professional, proactive demeanor.
  • 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.