Director, Regulatory Affairs

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

💵 £111.1k - £141.8k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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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 • Plan and perform critical reviews of documents for consistency and quality • Identify gaps in critical documentation to support successful registration and lifecycle management • Build intra- and inter-team relationships and collaborate globally on regulatory strategy and activities across 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 on clinical trial applications, marketing authorization applications, orphan drug designation applications, and pediatric submissions • Collaborate with strategic operations and other functions to provide regional regulatory insight • Serve as point of contact with Health Authorities and lead interactions with relevant authorities or external stakeholders • Review and interpret regulatory guidelines and create communication plans for impact assessments • Keep current with regulations and guidance documents and represent the regulatory function with leadership, ethics, and transparency • Lead development of regulatory strategies for assigned programs while reporting to the Vice President, Regulatory • Work with toxicology, pharmacology, and clinical development stakeholders to support IND-enabling and clinical-stage assets

🎯 Requirements

• A minimum of 10 years in the pharmaceutical industry • A minimum of 8 years in Global Regulatory Affairs • Experience with major Health Authorities (US FDA, Health Canada, UK MHRA and EMA) is mandatory • Minimum of 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, including experience working cross-functionally and on global teams

🏖️ Benefits

• Annual bonus eligibility • Equity compensation • Comprehensive benefits package • Remote-friendly work arrangement, with most work conducted from home • Occasional opportunities or expectations for travel to the London Office • Accommodations available on request for candidates taking part in all aspects of the selection process