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 four 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

Position Summary

The Senior 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

• 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 development and execution of the global regulatory strategy for development medicinal products.
• Anticipates and brings solutions for potential regulatory risks.
• Independently leads the regulatory submissions to obtain and maintain marketing authorisations in the European Union, Great Britain (GB) and Switzerland for one or more Seagen product.
• Supports health authority interactions required to develop a robust European regulatory strategy for one or more Seagen product.
• Independently leads the regulatory submissions of clinical trial applications (CTA) and amendments in Europe (EU, GB and Switzerland). Support for rest-of-the-world clinical trial applications may be required.
• Manages regulatory affairs consultants/service providers working on the CTA submissions.
• Helps the dissemination of the European regulatory strategy to the in-country regulatory contributors (this may be external consultants, distributors or internal Seagen personnel).
• May support the cross-functional European product brand teams to ensure alignment with the teams outside of the Development function.
• Researches and analyses 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.
• May act as line manager for regulatory professionals up to Associate Manager level.
• Supports the International Regulatory team as required.

Required Qualifications

• 8+ 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)
• Experience in the preparation/submission of regulatory documentation to support diverse regulatory procedures in Europe (European Union, Switzerland and United Kingdom) including clinical trials applications, marketing authorisation applications or variations (preferably via the European centralised procedure) and health authority interactions. Experience in the development of Oncology products would be an advantage.
• Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

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: 01/27/2023