Manager, Regulatory Affairs

23 Feb, 2021

Jobs

Manager, Regulatory Affairs

UniQure
Lexington, MA

uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Key results areas (major duties, accountabilities and responsibilities)

  • Support execution of global product development and registration including participation in the development and execution of regulatory strategies for all uniQure’s pipeline products and related support
  • Assist in the writing of global submissions for early and pivotal clinical studies to support regulatory
  • Provides regulatory perspective in the development of Target Product Profiles
  • Reviews promotional, advertising, and labeling items
  • Responsible for preparation/submission/maintenance of current and future INDs/CTAs/IMPDs/ODD and marketing applications. This includes:
    • Support of activities for Health Authority meetings
    • Submissions to NIH/RAC and EU regional GMO assessments Serving as a point of contact for Regulatory
  • Maintaining regulatory files and records of contact with Regulatory Authorities
  • Advising Clinical and CMC related functions (Clinical Operations, Process Development, Analytical Development, Manufacturing and  Quality Control) on the preparation and content  of  regulatory  submissions  to ensure timely delivery of final documents and maximize ‘right-first-time’ outcomes
  • Supporting regulatory interactions globally throughout the product lifecycle of uniQure’s pipeline to secure comprehensive development plans, Paediatric lnvestigational Plans (PIPs) and registration strategies etc
  • Follow the emergency of new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline
  • Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences

Qualifications & Skills

  • 5-8 years of Regulatory Affairs experience with in the biotech/pharmaceutical industry in both the pre-market and post-market setting
  • Bachelor or a higher scientific degree (MS)
  • Experience in biologics/vaccines/gene therapeutics preferred
  • Experience with international regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations
  • Specific experience with CMC and clinical development desired

Core competencies

  • Demonstrated ability to influence without authority. Personnel management experience a plus but not required. Excellent oral and written communication skills – experience in communicating with global, cross functional, cross-cultural, multi-disciplinary project teams including team members in country offices
  • Respectful and collaborative team player with both line and matrix management relationships
  • Ability to rapidly understand and analyze complex problems/situations; active participation and the management of projects leading to solution development and implementation.
  • Clear decision making
  • Record of influencing project teams, strategically and operationally to deliver on budget and within agreed upon timelines
  • Involved in implementing corporate strategies globally, ability to think creatively while ensuring transparency

Learn more here

Job posted: 2021-02-23