CMC Submissions and Information Management Lead

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radioconjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet the demand for our growing pipeline of RCs.

Introduction to the Role:

The CMC Regulatory Affairs, Submissions & Operations role is responsible for the hands-on execution and coordination of CMC regulatory activities across assigned programs. This role reports into the Associate Director, CMC Regulatory Affairs and partners closely with cross-functional stakeholders to ensure regulatory deliverables are developed, reviewed, tracked, and submitted accurately and on time.

The role is highly execution-focused and requires strong organizational skills, attention to detail, regulatory knowledge, and the ability to manage multiple concurrent deliverables. The successful candidate will be comfortable working within regulatory systems and submission processes while maintaining a strong understanding of the broader CMC regulatory objectives of each program.

Key Responsibilities

Regulatory Submission Execution

• Coordinate and execute CMC regulatory submission activities across development and commercial programs.

• Lead the development and authoring of complex CMC regulatory documents and submission content.
• Translate complex CMC and scientific information into clear, concise, scientifically sound regulatory narratives.

• Support preparation and compilation of CMC content for IND/CTA, NDA/BLA/MAA, supplements/variations, annual reports, and other regulatory submissions as applicable.
• Coordinate submission deliverables across CMC, Quality, Manufacturing, Analytical, Regulatory, and other functional teams.
• Track document development, review cycles, approvals, and submission readiness.
• Ensure CMC regulatory documents are completed according to established timelines and quality standards.
• Support responses to health authority questions and requests for information.

Regulatory Systems & Submission Operations

• Execute activities within the Enterprise Regulatory Vault (ERV) and other applicable regulatory systems.
• Maintain accurate submission records, metadata, document status, and regulatory correspondence.
• Coordinate document filing and archival activities in accordance with applicable processes.
• Support publishing, submission assembly, document formatting, and technical submission requirements.
• Ensure regulatory information and documentation remain accurate, current, and inspection-ready.
• Responsibility for change management as assigned
• Understands application of appropriate risk management across own activities

Project & Workflow Management

• Maintain CMC regulatory submission trackers, timelines, action logs, and deliverable plans.
• Proactively identify upcoming milestones, dependencies, and potential delays.
• Coordinate meetings, agendas, actions, and follow-up activities related to CMC regulatory deliverables.
• Escalate risks and issues to the Associate Director, CMC Regulatory Affairs or functional lead.
• Support multiple programs and submissions simultaneously while effectively prioritizing competing deadlines.

CMC Regulatory Content Support

• Draft, Author, Review CMC regulatory documents for completeness, consistency, formatting, and alignment with submission requirements.
• Support preparation and review of CMC regulatory documents and submission components.
• Coordinate cross-functional review and incorporation of comments.
• Maintain consistency of CMC information across regulatory documents and submissions.
• Develop and maintain submission templates, trackers, checklists, and other operational tools.

Process Improvement

• Identify opportunities to improve CMC regulatory submission processes, systems, and workflows.
• Contribute to development and implementation of standardized processes and best practices.
• Support continuous improvement of regulatory systems, document management, and submission execution.
• Promote efficient, consistent, and compliant ways of working across CMC Regulatory Affairs.

Health Authority Questions & Responses

• Drive CMC Regulatory Affairs activities related to Health Authority Questions (HAQs), information requests, and other post-submission regulatory correspondence.
• Assess HAQs from a regulatory and scientific perspective and develop an appropriate response strategy.
• Conduct cross-functional meetings to clarify questions, establish ownership, align on interpretation, and agree on response strategy and key messages.
• Partner with CMC subject matter experts to develop scientifically robust and regulatory-appropriate responses.
• Draft responses to complex or high-priority HAQs, and drive through the review workflow to endorsement/approval and delivery.
• Coordinate cross-functional review and ensure responses are accurate, consistent, complete, and aligned with the overall regulatory strategy.
• Provide regulatory assessment of proposed responses and identify potential follow-up questions, risks, or regulatory implications.
• Ensure responses are delivered within agreed timelines and meet applicable regulatory requirements.
• Track and compile HAQs across programs to create a database of questions to pull for future requests.
• Track commitments made to regulatory agencies based on HAQs

Qualifications & Experience

• Bachelor's degree in a relevant scientific, regulatory, or related discipline.
• Experience in Regulatory Affairs, preferably CMC Regulatory Affairs within the pharmaceutical, biotechnology, or related industry.
• Demonstrated experience supporting or executing regulatory submissions.
• Strong understanding of regulatory submission processes and documentation requirements.
• Experience working within regulatory information/document management systems; experience with Enterprise Regulatory Vault (ERV) is an asset.
• Strong organizational and project coordination skills with exceptional attention to detail.
• Ability to manage multiple deliverables and timelines in a fast-paced, matrix environment.
• Strong written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams and independently manage assigned responsibilities.
• A proactive, solutions-oriented approach to identifying and resolving operational issues.

Success in This Role

Success in this role means turning regulatory plans into high-quality, timely execution. The successful candidate will be highly organized, detail-oriented, proactive, and comfortable owning the operational details that enable CMC regulatory submissions and activities to run smoothly.

The role is particularly suited to someone who enjoys getting things done, keeping complex workflows moving, and ensuring that no submission detail falls through the cracks.

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com

 

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Annual base salary for this position ranges from 102,232.80 to 134,180.55.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

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