VP, Head EUCAN Regulatory Strategy

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Job Description

OBJECTIVES / PURPOSE

As a key member of the International RA leadership team, this role is responsible for establishing the strategic direction and implementation of regulatory strategies for Takeda products within the EUCAN region (Europe + Canada).

• Ensures the development of regional strategic regulatory approach in conjunction with Global RA Strategy that supports the full development strategy and provides regulatory direction and oversight into development plans to achieve optimal development and life cycle management plans for the EUCAN region and across the therapeutic areas (TAU).
• Set the vision for the team and drive engagement in EUCAN region.
• Is a strategic partner to GRA TAUs, EUCAN commercial and CMC, as well as partnering with Health Authorities.
• Lead EUCAN Regulatory Team to ensure regulatory activities are aligned with the commercial priorities for EUCAN BU and the European Research Centre Leadership Team; to support a strong and visible R&D community within Europe.

ACCOUNTABILITIES

• Provides regulatory expertise and ensures appropriate regulatory guidance and support is provided to development teams and established products across regions within the EUCAN Region.
• 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.

CORE ELEMENTS RELATED TO THIS ROLE

• 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.

DIMENSIONS AND ASPECTS LEADERSHIP

• 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

• Provide input to highly complex decisions that impact the functional area.
• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
• Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution.
• Accountable for providing input to and implementing vision and strategy for designated scope.

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.
• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions.
• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation.
• Comfortable challenging the status quo and bringing forward innovative solutions.
• Ability to take risks implementing innovative solutions, accelerating time to market.
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Role models respect and inclusion, creating a culture that fosters innovation.

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
• Deep expertise required.
• Ability to see and understand broader, enterprise level perspective.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

• Master’s or other advanced degree in science (MD, PhD, PharmD).
• Minimum of 18 years of relevant pharmaceutical industry experience with at least 10 years in Regulatory Affairs preferred.
• Good understanding of R&D and commercial processes and business needs.
• Experience in drug development (multiple therapeutic area, multiples phases of drug development).
• Experience in the region is required.

TRAVEL REQUIREMENTS :

• Requires willingness to travel to various meetings. May require travel approximately 20% of time.