Takeda Pharmaceuticals

Executive Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs, GI²


PayCompetitive
LocationRemote
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: R0103487

      By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

      Job Description

      About the role:

      Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Executive Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - GI ² (Inflammation & Immunology) remotely.

      Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Executive Director working on the Global Regulatory Affairs GI ² (Inflammation & Immunology) team, you will be empowered to provide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval.

      OBJECTIVES/PURPOSE

      • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval.
      • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization.
      • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.

      How you will contribute:

      ACCOUNTABILITIES

      • The Executive Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis.
      • Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
      • Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.
      • Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
      • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
      • Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within GI Area, across GRA and across R&D.
      • Provide regulatory strategy support to diligence for licensing opportunities as appropriate
      • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
      • Responsible for demonstrating Takeda leadership behaviors.

      DIMENSIONS AND ASPECTS

      Technical/Functional (Line) Expertise

      • Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience.

      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

      • Decision making responsibilities:
      • Provide input to highly complex decisions that impact the functional area
      • Accountable for decision making for designated function
      • 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-making, complexity of decisions, impact of decisions, problem-solving)

      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

      Innovation

      • 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

      Minimum Requirements/Qualifications:

      • Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted.
      • 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.
      • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
      • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
      • Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
      • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
      • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
      • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative
      • Solutions and strategies, including risk mitigation strategies.
      • Must work well with others and within global teams.
      • Able to bring working teams together for common objectives.
      • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.

      What Takeda can offer you:

      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursement

      More about us:

      At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

      Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

      Location and Salary Information:

      • This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
      • Base Salary Range: $198,100-$283,000 based on candidate professional experience level.
      • The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

      Empowering Our People to Shine

      Learn more at takedajobs.com .

      EEO Statement

      Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

      Locations

      USA - MA - Virtual

      Worker Type

      Employee

      Worker Sub-Type

      Regular

      Time Type

      Full time
  • About the company

      Hope and empathy. These two words are not often associated with pharmaceutical companies. But here at Takeda, our people are motivated to serve patients with integrity, respect, and empathy. Driven by our mission, we seek to bring hope of better health and a brighter future to those we impact. To do this, we focus on our chosen core therapeutic areas: Oncology Gastroenterology Neuroscience Develop life-saving vaccines No matter the region, business unit, function, or team, everyone at Takeda matters. Every one of our employees is a vital contributor to our bold, inspiring mission.