Director, CMC Regulatory Affairs

Director, CMC Regulatory Affairs at Recursion.

About the role In this pivotal position, you will be instrumental in developing and implementing CMC regulatory strategies for investigational small molecule drugs. Your extensive knowledge and experience will guide the preparation and submission of regulatory documents, ensuring adherence to international standards throughout the phases of clinical trials and marketing applications.

• Location:
  
  London, England;
  Oxford, England
• Engagement:
  Full-time
• Team:
  Development Team

• Lead the formulation and execution of CMC regulatory strategies for investigational drugs undergoing Phase 1-3 trials and for marketing submissions.
• Engage in collaborative discussions with team members to shape regulatory strategies, providing expert recommendations on drug substances and products to ensure compliance with US, EU, and global regulations.
• Plan, draft, and oversee the development of region-specific CMC submission documents, including Module 2, Module 3, and Investigational Medicinal Product Dossier (IMPD), while coordinating with both internal teams and external partners.
• Guarantee the submission of high-quality regulatory documents and provide strategic advice for markets in the US, EU, and globally.
• Review clinical trial materials, such as product labels and protocols, and assist with Good Manufacturing Practice (GMP) inspections as required.
• Continuously assess and identify risk mitigation strategies in light of changing GMP regulations and guidance both in the US and internationally.
• Collaborate with cross-functional teams to ensure that all regulatory requirements are met throughout the drug development lifecycle.
• Maintain an up-to-date knowledge of industry trends and regulatory changes to inform strategic decisions and ensure compliance.
• Mentor and guide junior staff in regulatory affairs practices, fostering a culture of continuous learning and improvement.
• Prepare for and participate in regulatory agency meetings, providing insights and updates on the CMC aspects of drug development.
• Develop and implement training programs for internal teams on CMC regulatory requirements and best practices.

• Comprehensive technical expertise in the development of small molecule drugs.
• A degree in a relevant scientific discipline (BA/BS, MS, or PhD);
  Regulatory Affairs Certification (RAC) is preferred. A minimum of 8 years of experience in CMC regulatory affairs, encompassing both drug product and drug substance.
• In-depth understanding of global CMC regulatory frameworks and directives, with a demonstrated ability to facilitate clinical research and manage lifecycle processes effectively.
• Proven experience with US and international regulations, offering strategic guidance and assisting cross-functional teams in fulfilling regulatory obligations.
• Capability to evaluate and manage risks associated with drug development across various jurisdictions.
• A successful history of producing high-quality Investigational New Drug applications (INDs), IND amendments, New Drug Applications (NDAs), and meeting packages, with experience in submissions to the US, EU, and other regions.
• Excellent verbal and written communication skills, with the ability to convey complex information clearly and effectively.

• Experience in managing multiple projects and priorities simultaneously, demonstrating strong organizational skills.
• Proven ability to collaborate effectively across various functions related to CMC aspects of drug development.
• Familiarity with advanced regulatory submission tools and software.

• Expertise in regulatory submission processes and documentation practices.
• Strong knowledge of GMP regulations and compliance standards, ensuring that all practices meet the necessary requirements.
• Proficient in using project management tools to track progress and ensure timely completion of regulatory submissions.

• This role offers the flexibility to work remotely, with occasional travel required to the Salt Lake City headquarters or other office locations.
• The anticipated annual base salary for this position ranges from £111,100 to £141,800.
• In addition to the base salary, the role includes eligibility for an annual bonus, equity compensation, and a comprehensive benefits package.

Recursion is dedicated to providing equal employment opportunities and encourages applications from all qualified individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

Accommodations are available upon request for candidates participating in the selection process, ensuring that all applicants have the opportunity to demonstrate their qualifications.