Seagen

Regulatory Affairs Manager Europe

Description

Summary

The Regulatory Affairs Manager, Europe, will report to and support the Regional Regulatory Lead for a product with an expanding clinical development program, with primary responsibility for supporting regulatory submissions and activities in line with the global regulatory plan.

Responsibilities:

• Provides effective operational and strategic regulatory support for assigned regulatory activities for an oncology medicinal product, including preparation and submission of variations, PSUR, RMP updates, responses to questions, renewals, via the European centralised procedure and national procedures, as required
• Collaborates with the cross-functional teams to ensure optimal execution of the agreed regulatory strategy
• Leads the compilation of the regulatory dossier to support clinical trial applications in Europe (EU, UK, Switzerland), provides advice on preparation of responses to CTA questions, amendments, notifications. Serves as the point-of-contact with regulatory service providers/vendors
• Provides strategic and tactical regional advice to cross-functional study teams to ensure successful and compliant conduct of the studies in Europe
• Supports the Regional Regulatory Lead in the submission of Paediatric Investigation Plans, Orphan Drug Designation applications, and other relevant European applications, as required.
• Anticipates, identifies and proposes solutions for potential regulatory risks
• Monitors the regulatory requirements in the EU, Switzerland and GB and communicates changes and related impact to cross-functional teams under the supervision of the regional regulatory lead
• Researches relevant regulatory precedents to formulate innovative regulatory approaches.
• Maintains and improves regulatory document preparation best practices and processes.
• Tracks and archives regulatory documentation, such as information requests, commitments, correspondence records, and approvals
• Supports the European Regulatory Affairs team, as required

Qualifications:

• Bachelor’s degree in a life sciences discipline; advanced degree desirable
• 5+ years of relevant experience in regulatory affairs with drug or biotechnology products
• Experience in the preparation/submission of regulatory applications via EU Centralized Procedure, including experience of managing an MAA or a major Type II Variation procedure
• Knowledge of the European drug development process and regulatory requirements (knowledge of ex-European regulatory environment would be an advantage)
• Experience of supporting multinational clinical trials, including European CTA applications and maintenance
• Excellent written and oral communication skills
• Strong interpersonal skills, self-motivation, cross-functional working and problem-solving skills
• Able to manage conflicting priorities and adhere to tight timelines
• Proven ability to work with a high level of integrity, accuracy, and attention to detail
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in a fast-paced environment

As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/12/2021