Manager, Regulatory Affairs – Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, organize, and provide regulatory submissions and documents that are ready for submission.

• Ensure streamlined and compliant document workflows among various departments.

• Offer expertise in the preparation of regulatory submission documents and dossiers.

• Coordinate and implement document workflows, including formatting and finalization for submission readiness.

• Utilize regulatory operations tools to uphold high standards of document quality across departments and adhere to agency specifications.

• Collaborate with teams regarding regulatory requirements and the preparation of compliant submission documents.

• Manage submission document workflows, plans, deadlines, and coordination across relevant functions and product portfolios.

• Keep abreast of global electronic submission trends related to eCTD document preparation.

• Engage in the maintenance of Regulatory Information Management Systems and Electronic Document Management Systems, including Veeva Submission and Archive Vaults.

• Comprehend and support eCTD publishing systems and readiness requirements for publishing.

• Develop and oversee document preparation processes utilizing templates and internal style guides.

• Enhance and support the regulatory operations document infrastructure, procedures, standards, templates, and style guides.

• Provide guidance, troubleshooting, and training on best practices for document creation and regulatory requirements.

• Propel process improvements and maintain quality standards for regulatory submissions.

• Assist Regulatory Operations management with submissions to Health Authority portals, RA SOW/PO system administration, and leadership metric reporting.

⛳️ Requirements

• A Bachelor's degree or equivalent experience is mandatory.

• A minimum of 7 years of experience in Regulatory Affairs Operations is required.

• Preferred experience with US/Canada and/or European regulatory legislation and procedures is essential.

• Proven experience in preparing documents for submission, including formatting, quality control, and finalization of regulatory documents for eCTD submissions such as NDAs and/or EU Marketing Authorization Applications.

• Strong organizational abilities and capacity to manage multiple projects and deadlines effectively.

• Exceptional attention to detail and accuracy in documentation.

• In-depth knowledge of CTD/eCTD structure, format, and submission requirements, including Lorenz docuBridge.

• Proficiency in MS Word, Adobe Acrobat, electronic publishing software, and document management systems like CSC Toolbox and Veeva Collaborative Authoring or equivalent.

• Strong project management skills with the ability to evaluate and advise teams on impacts or changes to project timelines.

• Excellent written and verbal communication abilities.

• Capability to work independently in a remote setting across multiple time zones while effectively collaborating in a team environment.

• A general understanding of dossier Life Cycle Management is preferred.

• Fluent in English, both spoken and written; proficiency in an additional European language is a plus.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work arrangements available throughout Telix.

• Supportive, engaged colleagues and a global interdisciplinary team.