Director, Regulatory Affairs

🔥 0 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

🗽 New York, Utah – Remote

🗽 New York – Remote ⛷️ Utah – Remote

💵 $207.5k - $255.2k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Recursion

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

💰 $150M Post-IPO Equity on 2022-10

Healthcare • Manufacturing • Consulting

Recursion is a pioneering biopharmaceutical company that leverages advanced technology to drive the industrialization of drug discovery. It combines hardware, software, and vast datasets to decode complex biological information, aiming to create a next-generation platform for developing therapeutics. With a focus on AI and collaboration with industry leaders like Exscientia, Recursion is at the forefront of TechBio, transforming the landscape of drug discovery and development. The company is a proud founding member of BioHive, underscoring its commitment to innovation and leadership in the life sciences sector. Operating with over 60 petabytes of proprietary data and a significant pipeline, Recursion aims to radically improve lives by exploring broad therapeutic areas in partnership with other entities.

📋 Description

• Support global regulatory strategy, oversee processes, and identify and manage regulatory risks for assigned programs • Collaborate with cross-functional leads to develop and implement regulatory strategies across applicable jurisdictions • Review documents for consistency and quality and identify gaps in critical documentation • Build intra- and inter-team relationships in a global team environment • Manage regulatory strategy and activities across the EU, US, UK and other applicable jurisdictions throughout product development and post-approval • Participate in global product team meetings and provide regulatory support and guidance • Manage day-to-day regulatory activities and coordinate multiple complex projects • Create and follow procedures for regulatory execution and implementation • Support program leads through Clinical Study Teams for clinical trial applications, marketing authorization applications, orphan drug designations, pediatric submissions and related activities • Collaborate with Strategic Operations, Clinical, Commercial, Medical Affairs and other functions on regional regulatory planning • Serve as a point of contact with Health Authorities and lead relevant external interactions • Review and interpret regulatory guidelines and create communication plans for impact assessments • Keep current with regulations and guidance through meetings, conferences, journals, newsletters and scientific papers • Lead development of regulatory strategies for assigned programs while reporting to the Vice President, Regulatory

🎯 Requirements

• Minimum 10 years in the pharmaceutical industry • Minimum 8 years in Global Regulatory Affairs • Experience with major Health Authorities: US FDA, Health Canada, UK MHRA and EMA • Minimum 8 years of experience with regulatory submissions, including INDs, NDA/NDS/MAA, post-marketing measures, PIP/PSP, ODD, BTD and EU PRIME activities • Strong understanding of regulatory strategy and implementation of operational activities • Outstanding management, interpersonal, communication, negotiation and problem-solving skills • Demonstrated organizational awareness • Experience working cross-functionally and on global teams • Oncology, rare disease and I&I experience is good to have

🏖️ Benefits

• Annual bonus eligibility • Equity compensation • Comprehensive benefits package • Remote-friendly work arrangement • Most work conducted from home • Occasional travel opportunities or expectations to Salt Lake City headquarters or other office locations