Seagen

Associate Director, Regulatory CMC

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 Associate Director, Regulatory CMC will be responsible for recruiting and managing staff in the EU and Canada and advising on regulatory strategies for drug products in the EU/Switzerland/UK in accordance with the goals of the company, applicable regulations, standards, and established procedures. The Associate Director will also provide global regulatory leadership in support of one or more development or commercial programs. This includes the development and implementation of global regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This position represents Regulatory CMC on multi-disciplinary teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application as well as post-approval life cycle management.

Principal Responsibilities

• Provide effective strategic and tactical leadership to support global regulatory plans including:
• Developing and implementing regulatory strategy and submission plans to support global pivotal clinical trials including regulatory authority meetings, INDs, CTAs, and marketing applications
• Conducting regulatory review of documents for health authority submissions
• Representing the regulatory function on cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy
• Providing regulatory guidance and strategy including identifying and assessing regulatory risks
• Serving as point of contact with regulatory authorities, as applicable
• Monitoring and researching regulatory intelligence, to bring innovative approaches to the cross-functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans
• Collaborating with global development partners

Qualifications

• Minimum of 8 years Regulatory CMC experience; advanced degree desirable
• Biologic product experience highly desirable
• Ability to oversee regulatory activities and manage process from research/discovery, clinical development through to commercialization and post-marketing maintenance
• Knowledge and understanding of global regulations and guidelines
• Familiarity with FDA IND/NDA/BLA, National European (Swiss, UK, others) regulatory processes
• EU Centralized Procedure expertise required (preferably an MAA, or as a minimum, major Type II Variations for new indications)
• Knowledge of EU procedures (fast to market procedures would be an advantage)
• Experienced with CTA submissions and maintenance, as well Scientific Advice
• Experience leading a team to prepare for and carry out major health authority interactions
• Line management experience advantageous
• Thorough understanding of local compliance, as well as a sound ethical approach to business

Education:

• PhD, PharmD, Masters or Bachelors degree in life sciences.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/09/2022