Associate Manager, Regulatory Affairs
vor 1 Woche
Position Summary:
The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate 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.
- 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
- Manages regulatory affairs consultants/service providers working on the CTA submissions
Anticipates and brings solutions for potential regulatory risks
- Researches 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 Seattle Genetics 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
Qualifications:
- 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 clinical trials
- 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
- #LI-LO1_
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