Seagen

Senior Regulatory Affairs Specialist

Position Summary:

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

Responsibilities:

• Supports the preparation of regulatory submissions for oncology marketed medicinal products via the European centralized procedure and national procedures as required. These submissions can include variations, PSUR, RMP updates, responses to questions and renewals, for example
• Assists in the review of product labelling and packaging and to ensure concordance with the marketing authorizations in the European Union, Switzerland and GB, and applicable labelling/packaging requirements
• Co-ordinates the compilation of the regulatory dossier to support clinical trial applications in Europe (EU, UK, Switzerland)
• Supports the Regional Regulatory Lead in the submission of Paediatric Investigation Plans, as required
• Collaborates with the cross-functional teams to ensure optimal execution of the agreed regulatory strategy
• Provides Regional Regulatory representation at cross functional team meetings such as study team meetings or submission working groups
• Responsible for monitoring regulatory requirements in the EU, Switzerland and GB and for communicating changes and related impact to cross-functional teams under the supervision of the regional regulatory lead
• Maintains and improves regulatory document preparation best practices and processes
• Tracks and archives regulatory activities 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 3+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent
• Experience in the preparation/submission of regulatory documentation to support regulatory submissions
• Excellent written and oral communication skills
• Ability to work well cross-functionally with various people and groups
• 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
• Ability to work in Zug, Switzerland, preferred

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/29/2021