Associate Director, CMC Regulatory Affairs in Oxford

Associate Director, CMC Regulatory Affairs in Oxford

Oxford Full-Time 88200 - 111100 £ / year (est.) No working from home possible
Recursion

At a Glance

  • Tasks: Lead CMC regulatory strategy for innovative drug development and global clinical trials.
  • Company: Join Recursion, a pioneering TechBio company transforming lives through advanced medicine.
  • Benefits: Competitive salary, annual bonus, equity compensation, and comprehensive benefits package.
  • Other info: Flexible remote work options with opportunities for career growth and collaboration.
  • Why this job: Make a real impact in healthcare by shaping the future of drug development.
  • Qualifications: 8+ years in CMC regulatory affairs with deep knowledge of drug development.

The predicted salary is between 88200 - 111100 £ per year.

Your work will change lives. Including your own.

The Impact You’ll Make

  • Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.
  • Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings.
  • Strategize, plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests.
  • Deliver high quality regulatory US, EU and ROW submissions, strategy and advice.
  • Support review of investigational product labels, protocols, investigator’s brochure, and other clinical trial materials; GMP inspections as needed.
  • Assess and identify on an ongoing basis, risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance.

The Team You’ll Join

As Manager/Director CMC Regulatory Affairs you will be an essential member of the Recursion Development Team reporting to the Vice President of Regulatory Affairs. The Development Team is an empowered, execution-minded group of development, manufacturing and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.

The Experience You’ll Need

  • Deep technical knowledge of small molecule drug development.
  • BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 8+ years’ experience in CMC regulatory (both drug product and drug substance).
  • Extensive command of worldwide CMC regulatory standards and directives for facilitating clinical research, securing international trial approvals, and life-cycle management.
  • Understanding of US and ex-US regulations, providing strategic advice, and supporting cross functional teams in navigating regulatory requirements and implementing change. US, EU and other Ex-US experience is required.
  • Assess and manage risks for drug development in all regions as applicable.
  • Demonstration of cross-functional understanding and technical team support related to CMC aspects of drug development.
  • Managing multiple projects and priorities.
  • Demonstrated track record of authoring and producing high quality INDs, IND amendments, NDAs, meeting packages and achieving timelines. US, EU and other Ex-US submission experience is required.
  • Excellent verbal and written communication skills.

Working Location & Compensation:

Making London or Oxford (Milton Park) your home base is ideal; however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is £88,200 to £111,100. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.

The Values We Hope You Share:

  • We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
  • We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
  • We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
  • We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
  • We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
  • We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.

Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.

More About Recursion

Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end‑to‑end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose‑built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter—faster, better, and at scale—for patients who are waiting.

Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation.

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.

We are committed to a high-performing workplace where everyone feels like they belong and can do the best work of their careers. We reward merit and contribution as we strive for a workplace that reflects the communities in which we operate and the patients we intend to serve.

Associate Director, CMC Regulatory Affairs in Oxford employer: Recursion

Recursion is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals in CMC Regulatory Affairs. With a commitment to employee growth, competitive compensation, and a comprehensive benefits package, Recursion empowers its team members to make a meaningful impact on patients' lives while working in vibrant locations like London and Oxford. The company's values of integrity, accountability, and urgency create an environment where employees can thrive and contribute to groundbreaking advancements in drug development.

Recursion

Contact Details:

Recursion Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Associate Director, CMC Regulatory Affairs in Oxford

Tip Number 1

Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.

Tip Number 2

Prepare for interviews by researching the company and its values. Understand their mission and how your skills align with their goals. This will help you stand out and show that you're genuinely interested in being part of their team.

Tip Number 3

Practice your pitch! Be ready to explain your experience and how it relates to the role. Keep it concise but impactful—think of it as your personal brand statement that highlights why you're the perfect fit for the Associate Director position.

Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us.

We think you need these skills to ace Associate Director, CMC Regulatory Affairs in Oxford

CMC Regulatory Strategy Development
Small Molecule Drug Development
Regulatory Submissions (INDs, NDAs)
GMP Regulations Knowledge
Cross-Functional Team Collaboration
Risk Assessment and Management
Project Management

Some tips for your application 🫡

Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your experience in CMC regulatory affairs and how it aligns with our mission at Recursion. We want to see how you can make an impact!

Showcase Your Achievements:Don’t just list your responsibilities; share specific achievements that demonstrate your expertise in drug development and regulatory submissions. We love seeing quantifiable results that show how you've contributed to past projects.

Be Clear and Concise:When writing your application, clarity is key! Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point while still showcasing your personality.

Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining the Recursion team!

How to prepare for a job interview at Recursion

Know Your CMC Inside Out

Make sure you have a deep understanding of CMC regulatory strategies, especially for small molecule drugs. Brush up on the latest US and EU regulations, as well as any specific guidelines relevant to the role. This knowledge will help you answer questions confidently and demonstrate your expertise.

Prepare Real-World Examples

Think of specific instances where you've successfully navigated complex regulatory challenges or contributed to high-quality submissions. Be ready to discuss these examples in detail, highlighting your problem-solving skills and ability to manage multiple projects simultaneously.

Showcase Your Communication Skills

Since this role involves collaboration with cross-functional teams, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've effectively communicated regulatory strategies and influenced stakeholders in previous roles.

Align with Company Values

Familiarise yourself with Recursion's values and think about how your own experiences align with them. Be prepared to share examples that reflect your commitment to integrity, accountability, and collaboration, as these traits are crucial for success in their team-oriented environment.