Director, Regulatory Affairs

Segment (Twilio); New York (NY); On-site; USD 207,500 - 255,200; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Comprehensive benefits

Job summary

Recursion is seeking a Director of Regulatory Affairs to drive global regulatory strategy for assigned programs and manage regulatory risk across jurisdictions. The role collaborates with Clinical, Commercial, and Medical Affairs, and supports interactions with health authorities to enable registrations and lifecycle management.

The position requires extensive experience in regulatory submissions and a track record of leadership in a global team, with remote-friendly work and occasional travel

Qualifications

• Minimum 10 years in the pharmaceutical industry with 8+ years in Global Regulatory Affairs.
• Experience with major Health Authorities (US FDA, Health Canada, UK MHRA, EMA) is mandatory.
• Strong regulatory strategy and cross-functional collaboration required.

Responsibilities

• Build intra- and inter-team relationships to manage regulatory strategy across jurisdictions.
• Manage multiple regulatory projects with risk assessment and prioritization.
• Create and enforce procedures for regulatory execution and coordinate with CSTs.
• Collaborate with Clinical, Commercial and Medical Affairs to inform regulatory planning.
• Serve as primary contact with Health Authorities as needed.
• Review guidelines and communicate impact; influence regulatory science innovation.

Skills

Management

Interpersonal skills

Communication

Negotiation

Problem-solving

Job description

Your work will change lives. Including your own.

The Impact You’ll Make

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 a 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.

In this role, you will:

• 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

The Team You’ll Join

Reporting to the Vice President, Regulatory, you’ll lead the development of regulatory strategies for assigned programs. You’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND‑enabling and clinical‑stage assets) in alignment with Recursion’s regulatory strategy.

The Experience You’ll Need

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

Working Location & Compensation:

This role is remote‑friendly, with most work conducted from home. There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations.

In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.

• Salt Lake City & all other U.S. locations: $207,500–$255,200

Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.

Accommodations are available on request for candidates taking part in all aspects of the selection process.