Seagen

Associate Manager, Regulatory Operations

Development - Zug, Switzerland

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

Reporting to a (Senior) Manager of Regulatory Submission Management (RSM), the Associate Manager of RSM provides strategic and tactical execution of submissions in Europe. The Associate Manager will ensure the successful planning, coordination, QC, and execution of all submissions to the European Union, and other European countries where appropriate, Health Authorities in eCTD, NEES, and hybrid formats. They will oversee submission, and dossier life-cycle maintenance activities in European regions to which Seagen has on-going investigational and marketing applications. The role, in partnership with Regulatory Information Management (RIM), will manage the archival of Regulatory submission documents, help establish procedures and best practices for electronic data management, and serve as a technical expert in publishing for the European region. Expertise will include basic knowledge of publishing guidelines in various European regions and the Regulatory tools used to generate compliant documents and submissions. They may train a group of junior submission managers, help establish publishing processes, and train cross-functional teams on submission ready documents. This role will support the RIM group during the configuration, testing, implementation, and upgrade of Regulatory systems, especially to address European requirements. They will participate in Global Regulatory Teams (GRTs) and serve as individual contributors to Submission Working Groups (SWGs). The role will support Global Regulatory Leads in the timely execution of Product specific submissions and milestones in support of company goals.

Principal Responsibilities:

• Manage the preparation and lifecycle maintenance of regulatory dossiers (CTA, IMPD, MAA, etc.) in ICH eCTD format, or hybrid format, for submission to European regulatory authorities (e.g. EMA, Switzerland, UK, etc.) within agreed upon corporate timeframes. Also on occasion, support the larger RSM team with submission in other global regions.
• Collaborate with Global Regulatory Leads and Global Regulatory Teams to develop and maintain regulatory submission content plans and ensure high quality submissions to European regulatory authorities.
• Oversee submission, and dossier life-cycle maintenance activities in European regions to which Seagen has on-going investigational and marketing applications.
• May serve as an administrator to country specific portals and gateways to the EMA, MHRA, and Swissmedic Help optimize current electronic submission processes, planning tools, and establish timelines for document hand-offs for the facilitation of orderly and timely regulatory submissions.
• Enforces documentation standards, templates, and procedures related to the Word formatting, publishing, and archiving of Regulatory submissions, commitments, and correspondence.
• Manage the archival of Regulatory documents and help establish procedures and best practices for electronic data management in the RIM system.
• May represent Regulatory Operations in partnerships with Contract Research Organizations and external partners, executing on timely deliverables as needed.
• Maintain knowledge of current and upcoming publishing standards, procedures, and data specifications in Europe.
• Contributes to the planning, execution, process development, and lifecycle maintenance of regulatory systems.
• May coach, mentor, develop, and manage performance of junior Regulatory Submission Management team members in Europe to maximize their contributions and personal growth.
• Manage interactions with European Health Authorities in relation to submission gateways as necessary.

Qualifications:

• At least 3 years of experience in Regulatory Affairs/Regulatory Operations in the pharmaceutical/biotechnology industry.
• At least 3 years of experience in building and validating successful various EMA, and other European regions, eCTD submissions.
• Knowledge of eCTD standards for European regions including document rendering, electronic submission publishing, and validation.
• Demonstrated understanding of drug development and regulatory processes and requirements for Europe, and preferably globally (specially for USA and Canada would be helpful).
• Demonstrated strong expertise in project management in relation to development of content plans, managing submission documents through work streams, and overall coordination of submission activities.
• Demonstrated experience in leading without authority .
• Proficiency with Veeva Vault RIM and Lorenz DocuBridge systems and processes preferred.
• Thorough understanding of local compliance, as well as a sound ethical approach to business.

Education

• Bachelor’s degree in related technical/scientific field, or equivalent experience.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/25/2022