Senior Director, Global Regulatory Lead, Global Regulatory Affairs - GI -

Company: Takeda Pharmaceutical
Location: Rochester
Posted on: November 14, 2023

Job Description:

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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 a Senior Director, Global Regulatory Lead, Global Regulatory Affairs - GI - (Inflammation & Immunology) based in Cambridge, MA.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs GI - (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

Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
Is a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.
Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
Accountabilities:
The Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
Ensures project team colleagues, 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 team and management; understands probabilities of technical success for the solutions.
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.
Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed.
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.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
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.
Lead regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
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.

How you will contribute:

ACCOUNTABILITIES

The Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
Ensures project team colleagues, 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 team and management; understands probabilities of technical success for the solutions.
Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.
Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed.
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.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
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.
Lead regulatory reviewer in due diligence for licensing opportunities.
Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
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.

Minimum Requirements/Qualifications:

BSc Degree, 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 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 creative 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:

Location: Cambridge, MA
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

Boston, MAWorker Type

EmployeeWorker Sub-Type

RegularTime Type

Full time

Keywords: Takeda Pharmaceutical, Rochester , Senior Director, Global Regulatory Lead, Global Regulatory Affairs - GI -, Executive , Rochester, New York