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 a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs in Cambridge remotely.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Senior Director working on the Global Regulatory Affairs Oncology team, you will be empowered to p rovide 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, and a typical day will include:
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.
The Senior 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 Therapeutic 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
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)
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
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:
Advanced degree in a scientific subject area (eg 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:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
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
This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.
Empowering Our People to Shine
Learn more at takedajobs.com .
No Phone Calls or Recruiters Please.
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
New York - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type