Associate Director of Regulatory Affairs

Summary

Join a dynamic team at Recursion, where you'll play a critical role in supporting global regulatory strategy and overseeing processes. As an Associate Director of Regulatory Affairs, you'll collaborate with cross-functional leads to develop regulatory strategies and implementation for all jurisdictions. You'll also plan and perform critical reviews of documents for consistency and quality, and identify gaps in critical documentation.

Requirements

• A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory
• Minimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP)/(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory
• Strong understanding of regulatory strategy and implementation of operational activities
• Outstanding management, interpersonal, communication, negotiation, and problem-solving skills

Responsibilities

• Build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdiction (e.g. EU, US, UK) for the global development of products through all stages of development and post approval
• Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities
• Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long term impact on program)
• Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.)
• Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions
• Collaborate with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program
• Serve , as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders
• Review and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients

Benefits

• Estimated current annual base range for this role is: Developing: $152,000 Skilled: $168,000 Expert:  $186,000
• Bonuses and equity compensation
• Comprehensive benefits package for United States based candidates