Associate Director, Regulatory Affairs

Recursion•New York, NY

1d•Remote

About The Position

Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking an Associate Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. Collaborate with cross-functional leads to support the development of regulatory strategies and implementation for all jurisdictions as applicable to the program. Plan and perform critical reviews of documents for consistency and quality, and identify gaps in critical documentation in alignment with the regulatory strategy with the intention of achieving successful registration and lifecycle management of unique products.

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 8 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.
Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams

Nice To Haves

Oncology, rare disease and I&I is good to have.

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.
Learn: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.
Represent regulatory function and demonstrate respectful behavior, leadership, ethics and transparency