Manager, Regulatory Affairs

vor 2 Wochen


Zug, Schweiz Seagen Vollzeit

Position 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 regulatory and operational support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives
- Lead the regulatory submissions of variations to the marketing authorisations and post-approval measures to the EMA (Centralised Procedure) and to Swissmedic
- Contribute to the global regulatory strategy by actively bringing the European insights into discussions
- Represent 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
- Manage regulatory affairs consultants/service providers
- Anticipate and brings solutions for potential regulatory risks
- Research relevant regulatory precedents to bring innovative approaches to the cross functional team
- Maintain excellent knowledge of the European regulatory landscape and pro-actively assesses impact of changes on Seattle Genetics programs
- Communicate and educate cross-functional teams on European regulatory requirements
- Maintain effective archiving and submissions/approvals tracking records
- Participate in process improvement initiatives as required
- Support the European Regulatory team as required

Required Qualifications:

- BSc; MSc or PhD in a life sciences discipline
- Fluent in English (written and spoken)
- Experience in the maintenance of regulatory marketing authorisations, ideally in Europe
- 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
- German language skills would be appreciated but not essential
- 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



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