Director - Global Regulatory Affairs - GI and Inflammation
Takeda, Cambridge, MA, United States
The Global Regulatory Leads, Director ensures that Takeda gains regulatory approval for new products and product amendments while maintaining the currency of product licenses and permits. This role involves developing and implementing regulatory strategies, managing compliance projects, and leading multidisciplinary teams to achieve organizational goals.
How you will contribute: Develop and implement regulatory strategies to ensure compliance with global standards Manage complex compliance projects, ensuring alignment with organizational goals Lead multidisciplinary teams, providing direction and support to achieve project objectives Coordinate and oversee project management activities, ensuring timely completion of tasks Apply problem-solving skills to anticipate and address challenges in regulatory processes Communicate effectively with stakeholders at all levels, including government officials Plan and execute long-term strategic plans aligned with global regulatory requirements
Skills and qualifications: Develops and implements regulatory strategies to ensure compliance with global standards Manages complex compliance projects, ensuring alignment with organizational goals Leads multidisciplinary teams, providing direction and support to achieve project objectives Coordinates and oversees project management activities, ensuring timely completion of tasks Applies problem-solving skills to anticipate and address challenges in regulatory processes Communicates effectively with stakeholders at all levels, including government officials Plans and executes long-term strategic plans aligned with global regulatory requirements Manages risks associated with regulatory affairs and compliance Engages with stakeholders to ensure their needs are met and to foster collaborative relationships Identifies and implements process improvements to enhance regulatory operations Utilizes analytical skills to assess regulatory landscapes and make informed decisions Makes critical decisions under pressure, ensuring the integrity and accuracy of regulatory submissions
As a recognized expert within Takeda globally, you possess in-depth expertise in your discipline and broad knowledge across related areas. You're adept at anticipating internal/external challenges, recommending improvements, and solving unique, far-reaching business problems.
Your role involves working on abstract issues, assessing intangible variables, contributing to global Business/Functional strategy, and serving as the primary contact for contracts and operations, conducting briefings and meetings with top management and customers. Operating with significant autonomy in a complex environment, you also lead project teams to achieve milestones and objectives.
Objective / 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 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 global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. 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. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. 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. Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ 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 relates 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 strong 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.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. #J-18808-Ljbffr
How you will contribute: Develop and implement regulatory strategies to ensure compliance with global standards Manage complex compliance projects, ensuring alignment with organizational goals Lead multidisciplinary teams, providing direction and support to achieve project objectives Coordinate and oversee project management activities, ensuring timely completion of tasks Apply problem-solving skills to anticipate and address challenges in regulatory processes Communicate effectively with stakeholders at all levels, including government officials Plan and execute long-term strategic plans aligned with global regulatory requirements
Skills and qualifications: Develops and implements regulatory strategies to ensure compliance with global standards Manages complex compliance projects, ensuring alignment with organizational goals Leads multidisciplinary teams, providing direction and support to achieve project objectives Coordinates and oversees project management activities, ensuring timely completion of tasks Applies problem-solving skills to anticipate and address challenges in regulatory processes Communicates effectively with stakeholders at all levels, including government officials Plans and executes long-term strategic plans aligned with global regulatory requirements Manages risks associated with regulatory affairs and compliance Engages with stakeholders to ensure their needs are met and to foster collaborative relationships Identifies and implements process improvements to enhance regulatory operations Utilizes analytical skills to assess regulatory landscapes and make informed decisions Makes critical decisions under pressure, ensuring the integrity and accuracy of regulatory submissions
As a recognized expert within Takeda globally, you possess in-depth expertise in your discipline and broad knowledge across related areas. You're adept at anticipating internal/external challenges, recommending improvements, and solving unique, far-reaching business problems.
Your role involves working on abstract issues, assessing intangible variables, contributing to global Business/Functional strategy, and serving as the primary contact for contracts and operations, conducting briefings and meetings with top management and customers. Operating with significant autonomy in a complex environment, you also lead project teams to achieve milestones and objectives.
Objective / 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 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 global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. 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. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. 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. Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ 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 relates 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 strong 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.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. #J-18808-Ljbffr