Seagen

Manager Regulatory Affairs

Development - Zug, Switzerland

Description

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to three marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information about Seagen can be found at www.Seagen.com

Summary:

The Regulatory Affairs Manager will report to and support the Regulatory Affairs Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products.

Principal Responsibilities:

• Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives
• Provide support for EU and Swiss MAA submissions
• Contributes to the global regulatory strategy by bringing the European insights into discussions
• Represents EU regulatory in cross-functional teams (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the regulatory strategy for development medicinal products
• Anticipates and brings solutions for potential regulatory risks
• Research relevant regulatory precedents to bring innovative approaches to the cross‑functional team
• Maintains excellent knowledge of the European regulatory landscape and pro-actively assesses impact of changes on Seagen programs
• Communicates and educates cross-functional teams on European regulatory requirements
• Maintains effective archiving and submissions/approvals tracking records
• Participates in process improvement initiatives as required
• Supports the European Regulatory team as required

Required Qualifications:

• 5+ years in drug development including 3 years managing regulatory submissions, with a primary focus on clinical trial applications and associated tasks
• BSc; MSc or PhD in a life sciences discipline
• Fluent in English (written and spoken)
• Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)
• Thorough understanding of local compliance, as well as a sound ethical approach to business

Preferred Qualifications:

• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
• Strong technical/analytical skills to identify and solve problems independently
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Ability to balance regulatory objectives with business objectives
• Willingness to work collaboratively and incorporate diverse perspectives into decision-making
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting
• Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality Proactively seeks out and recommends process improvements
• Entrepreneurial, enjoys working in a fast-paced, small-company environment

Education

• BSc; MSc or PhD in a life sciences discipline

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/26/2022