VP, Head EUCAN Regulatory Strategy

Description

• Provides regulatory expertise and ensures appropriate regulatory guidance and support is provided to development teams and established products across regions within the EUCAN Region (Europe + Canada).
• Provides leadership and drives functional aspects of the EUCAN regulatory process to ensure timely filing and approval of new products and maintenance of existing products in territories of responsibility in accordance with business objectives.
• Collaborates with senior management to provide planning, development and implementation of appropriate regulatory strategies to ensure ongoing compliance with regulatory requirements within the Region
• Directly manages, supervises and coaches the EUCAN RA team which is a team of regulatory professionals that provides day to day support and expertise between the project teams
• Responsible for regulatory input to all global regulatory development plans / strategies for all areas within Region.
• Has strong understanding of the commercial dynamics of the Region as it relates and impacts regulatory strategies and issues for the region. Has experience in working closely with Region commercial personnel
• Provides insight and continual research into future direction of EU Regulatory Affairs and how to best prepare for emerging trends, regulations and changes, enabling Takeda to take a proactive approach and proactive planning to future business requirements.
• Maintains regulatory intelligence for territories of responsibility
• Provides RA guidance and support for individual territory regional development activities.
• Oversees in-license RA activities identified by the Region Business Unit
• Demonstration of successful submissions / management for EUCAN, as well as fundamental knowledge of regulatory processes within US and Japan.
• Outstanding interpersonal, communication and organizational skills are required as this position works cross-functionally with development functions / staff.
• Proven track record in managing global, cross-functional projects or organizations
• Specific experience in rarely occurring, highly visible / highly important regulatory interactions such as participating in / preparing the project team for key Health Authorities
• Thorough knowledge of the drug development process, with focus on CTA and MAA processes. Experience with biologics and small molecule products and working with international regulatory agencies.
• Demonstrated ability to interface with relevant regulatory authorities.
• Excellent regulatory judgment and knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
• Results driven and team-oriented with the ability to influence outcomes.
• Must be able to innovate, analyze and solve problems with minimal supervision and have exceptional attention to detail.
• Excellent project and time management skills needed to drive multiple complex projects simultaneously.
• Demonstrated ability to lead and motivate a global staff. Ability to work collaboratively as a partner, at all levels, while maintaining successful relationships.
• Ability to function at a very high level of independence within a highly matrixed environment.
• Excellent leadership and management skills. Excellent written and oral communication skills.
• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry
• Demonstrated ability to work across functions, regions and cultures
• Functional level leadership with the ability to inspire, motivate and drive results
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company
• Ability to distil complex issues and ideas down to simple comprehensible terms
• Demonstrates leadership presence and confidence
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
• Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
• Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

Interaction

Innovation

Complexity

TRAVEL REQUIREMENTS :

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time