Careers

Director/Sr Director, Regulatory Affairs 

Description

Neoleukin Therapeutics is looking for an experienced and operational leader in regulatory affairs to join our fast-growing organization. This key position will manage all regulatory activities and processes to support clinical trials (pre-IND through Phase 1-4) in oncology and autoimmunity. If you are a resourceful, strategic and collaborative regulatory expert looking for an opportunity to build something unique, please apply!  


Responsibilities

  • Provide proactive and strategic regulatory leadership and contribute to a company-wide culture of regulatory awareness and excellence 
  • Provide guidance on the context and applicability of US and relevant global regulatory requirements to support clinical development goals 
  • Monitor current and emerging  regulatory guidance from US and relevant global bodies and adapt company regulatory policies accordingly 
  • Develop and implement strategies for global market penetration and identify regional regulatory partnership opportunities 
  • Identify and mitigate potential regulatory risks to business strategy and operations 
  • Review and approve clinical trial documents to ensure compliance with regulatory requirements and strategy 
  • Ensure submissions of regulatory documents occur on time and meet the highest standard of quality 
  • Oversee maintenance of internal clinical and regulatory documentation archives 
  • Develop, implement and enforce regulatory processes 
  • Ensure the operational success of regulatory affairs and activities 
  • As department head, assess hiring needs and provide leadership to the regulatory team, including feedback and mentorship with a goal of maximizing employee development 
  • Help develop and oversee the budget for regulatory affairs, authorizing expenditures, forecasting outlays and communicating variances 
  • Communicate the regulatory status of company projects to leadership 
  • Disseminate regulatory expectations to internal teams and external CROs 
  • Lead the interactions, negotiations and supervision of the regulatory activities of CROs 
  • Serve as lead contact and attend meetings with regulatory authorities 
  • Provide cross-functional support to prepare for regulatory meetings


Qualifications

  • Bachelor’s degree from a four year accredited university required 
  • Minimum of 10 years of regulatory affairs experience in the pharmaceutical/biotech industry required, including 3 years of early-phase clinical drug regulation preferred 
  • Strong understanding of US and global regulatory guidelines as they apply to pharmaceutical drug development 
  • Extensive experience in successful submissions of regulatory documents, including INDs and BLAs, and managing interactions with regulatory agencies 
  • Experience developing and implementing regulatory strategies and leading and managing regulatory teams and operations 
  • Experience with biopharmaceutic lifecycle management preferred 
  • Experience in oncology and biologics preferred 
  • Experience leading a team of collaborative clinical professionals 
  • Strong leadership skills and self-awareness, with proactive and positive management approach 
  • Excellent oral, written, and medical communication skills required 
  • Ability to thrive in a fast-paced and entrepreneurial environment 
  • Ability to function at a high level in a team setting whether leading the group or contributing independently 
  • Flexibility to adapt to changing needs in real time 
  • Ability to build strong relationships with co-workers of various backgrounds and expertise 
  • Excitement about the vision and mission of Neoleukin Therapeutic 

 

Applications can be submitted to careers@neoleukin.com

Neoleukin Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and Neoleukin will not tolerate discrimination or harassment based on any of the above characteristics.