Head of Regulatory Affairs International

Jobinhalt

Description

Position at Seagen

Summary

The Head of Regulatory Affairs International provides leadership and oversight of a team of international regulatory staff in support of multiple early- and late-phase development programs at Seagen. This includes oversight of the input and implementation of global regulatory strategies, ensuring timely preparation, review and submission of global marketing applications and clinical trial applications to regulatory authorities to enable patient access to promising new therapies.

This role requires an ability to coach and mentor staff to ensure successful health authority interactions, to enable successful regulatory outcomes, collaborating with internal and external development partners, and communicating with company leadership. The successful candidate will serve as a resource to team members for strategic and tactical advice, regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the marketing application and life-cycle management.

Responsibilities

• Oversee a team of international regulatory leads tasked with the development and implementation of global regulatory strategies
• Provide regulatory guidance, strategic and tactical advice to project teams and management, including identifying and assessing regulatory risks, managing issues, and finding solutions for complex problems
• Ensure the regulatory leads have appropriately defined the ex-US strategy and review submissions to regulatory authorities in-depth, to ensure successful communication of that strategy to the regulators (EMA, Swissmedic, MHRA, Health Canada, PMDA, etc.)
• Oversee strategy for and compilation of clinical trial applications to support the conduct of global clinical trials
• Serve as the International regulatory representative on the European and International Leadership Team and on Regulatory Senior Leadership Team
• Effectively communicate the specific ex-US considerations for company’s global activities.
• Collaborate with global development partners and commercial partners to align on regulatory strategies that are in the best interest of both parties and drug development
• Facilitate the communication with and provide strategic direction to country affiliate regulatory contacts
• Oversee development and presentation of regulatory strategies for governance milestones
• Support ex-US expansion initiatives providing regulatory guidance for territories of interest
• Evaluate intelligence on regulatory matters that may affect ongoing development programs and communicate implications of such intelligence
• Oversee the preparation of meeting requests and briefing documents, and the coordination and preparation of teams for health authority meetings
• Conduct diligence activities for potential in-license and acquisition opportunities
• Ensure appropriate regulatory resourcing and budgeting to meet the company objectives
• Manage, train and mentor regulatory affairs personnel
  

Requirements

• MD, MS, BS, PhD or PharmD qualification (or comparable)
• 15+ years of experience in an international Regulatory Affairs function, preferably in oncology
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, ideally gained with a US-headquartered company
• Knowledge and understanding of global regulations and guidelines
• Previous experience in the preparation and submission of MAAs or major Type II Variations/Line Extensions
• Previous experience in attending and leading a team to prepare for health authority interactions (e.g., EU oral explanations/scientific advice, Rapporteur meetings, pre-CTA meetings, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• Ability to work in a cross-functional team environment
• Strong attention to detail and the ability to handle multiple tasks
• Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  

Other Requirements Include

• Strong interpersonal skills including verbal and written communication
• Proven abilities to influence cross-functionally
• Strong leadership and conflict resolution skills
• Entrepreneurial, hands-on, and with a getting-things-done mentality
• Able to work independently and effectively in complex, rapidly changing environments; stress-resilience and ability to stay calm in hectic situations
• Sense of urgency, combined with flexibility, diplomacy, and the ability to manage expectations
• Strong presentation/interaction and time management skills
• Proven ability to establish strong partnerships with key internal and external stakeholders
• A true passion for science and in making a difference in patient’s lives
  

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 visitwww.Seagen.com.

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