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Director, Global Regulatory Affairs, Marketed Products

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Job ID R0041018 Date posted Aug. 19, 2021 Location Cambridge, Massachusetts

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Job Description

OBJECTIVES:

  • 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 both in the department and within R&D, 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 Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs 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.

  • Proactively anticipates 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 Director will lead all submission types.

  • Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff 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.

  • 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc Degree, preferred.  BA accepted.

  • 10+ years of pharmaceutical industry experience.  This is inclusive of 8 years of regulatory experience or combination of 6+ 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.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

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This job posting excludes CO applicants.

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

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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