Director/Sr. Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecule) - Remote

Initial Therapeutics, Inc.; San Francisco (CA); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Director/Sr. Director of Regulatory Affairs CMC to spearhead global regulatory strategies for small molecules. This pivotal role involves collaborating closely with cross-functional teams to ensure compliance and timely submissions for clinical development and marketing applications. The ideal candidate will have a robust background in CMC regulatory affairs, with a proven track record in managing multiple projects and regulatory submissions. Join a forward-thinking company committed to innovative drug design and patient care, where your expertise will contribute significantly to advancing therapeutic solutions in the biopharmaceutical landscape.

Qualifications

• 12+ years in CMC Global Regulatory Affairs with a focus on small molecules.
• Strong technical writing and communication skills required.

Responsibilities

• Develop and execute global CMC regulatory strategy.
• Lead preparation of high-quality global submissions for regulatory approval.

Skills

CMC Global Regulatory Affairs

Technical Writing

Project Management

Communication Skills

Regulatory Strategy

Drug Development Knowledge

Risk Mitigation

Team Collaboration

Education

Bachelor's degree in life sciences

Advanced degree in related field

Tools

MS Project

Smartsheet

Excel trackers

eCTD software

Job description

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs CMC (Head of Regulatory CMC, small molecules) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the VP, Head of Regulatory Affairs, other cross-functional colleagues and manage a small team of regulatory CMC experts. This role will be responsible for developing and executing the global CMC regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, CMC submissions in support of clinical development, registration and life cycle management activities. This position works cross-functionally with regulatory affairs and technical operations to facilitate the completion of CMC regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.

Responsibilities:

• Develop a comprehensive CMC regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, and effective regulatory agency interactions to support planned filings.
• Identify potential risks and mitigation strategies associated with proposed strategies.
• Represent Regulatory Affairs on assigned cross-functional development teams.
• Lead and manage the development and preparation of high-quality global submissions (including IMPDs and M3 for IND, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable.
• Support communication with global Health Authorities (HA), such as FDA and EMA, including planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
• Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
• Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges. Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence.
• Ensure adherence to current regulations associated with regulatory activities.
• Work strategically with all regulatory functions to develop detailed, actionable submission plans, track major submission deliverables, and ensure consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications.
• Play an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management.
• Track the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies.
• Develop and maintain submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs.
• Participate in cross-functional process initiatives impacting regulatory submission processes and systems.
• Manage consultants and contractors as needed.

Experience and Skills:

• Bachelor's degree in life sciences or related scientific discipline; advanced degree preferred.
• Minimum of 12 years in CMC Global Regulatory Affairs strategy with experience in expedited program development preferred.
• Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
• Experience in addressing CMC-related regulatory queries from global health authorities.
• Experience with all phases of pharmaceutical development and related implementation of phase-appropriate regulatory CMC requirements and strategies.
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications.
• Demonstrated success driving drug product development and managing all aspects of CMC documentation.
• Strong knowledge of drug development, FDA, EMA and ICH guidelines and other global regulations.
• Prior experience as primary author of CMC sections of M2 and M3 of IND and NDA, and IMPD.
• Fluency with eCTD structure, differences in regional dossier requirements, and software tools commonly used to author, review, format, and approve submission documents.
• Excellent attention to detail, and strong computer and organizational skills required.
• Strong team player who is fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Quality mindset and ability to deliver results in an ethical and positive manner.
• Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
• Proven ability to manage multiple tasks and associated deadlines.
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA.
• Strong project management and critical thinking skills.
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions.
• Excellent organizational and communication skills, both written and verbal.
• Ability to work independently as well as part of a team environment.
• Positive attitude, energetic and proactive.
• Proven ability to manage multiple projects, identify and resolve regulatory issues.
• Strong interpersonal skills and the ability to effectively work with others.

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