Takeda
Associate Director - Global Regulatory Affairs - GI & Inflammation
Takeda, Cambridge, Massachusetts, us, 02140
The Global Regulatory Affairs, Senior Manager is responsible for ensuring the organization gains regulatory approval for new products and product amendments, and for maintaining the currency of product licenses and permits. This role helps Takeda navigate complex regulatory landscapes to bring innovative therapies to market, supporting the company's mission to improve patient health globally.
How you will contribute:
Develop and implement regulatory strategies for new drugs
Guide teams through the drug development processes
Manage complex submissions for biologic licensing
Lead teams effectively, fostering a collaborative environment
Engage with government bodies to facilitate swift approval processes
Analyze and resolve complex regulatory issues
Communicate effectively with various stakeholders
Manage multiple projects simultaneously
Mentor junior staff, providing guidance and support
Innovate regulatory processes to improve internal standards
Skills and qualifications:
Develops and implements regulatory strategies for new drugs, applying advanced understanding of regulatory requirements
Guides teams through the drug development processes with a comprehensive knowledge of pharmaceutical and medical device regulations
Manages complex submissions for biologic licensing, demonstrating in-depth expertise in regulatory guidelines
Leads teams effectively, fostering a collaborative environment and focusing on skill development and professional growth
Engages with government bodies to facilitate swift approval processes, leveraging strong negotiation and communication skills
Analyzes and resolves complex regulatory issues, using critical thinking to maintain compliance and advance business objectives
Communicates effectively with various stakeholders, ensuring clarity and alignment on regulatory matters
Manages multiple projects simultaneously, prioritizing tasks to meet deadlines and organizational goals
Mentors junior staff, providing guidance and support to enhance team capabilities
Innovates regulatory processes, contributing to the improvement of internal standards and practices
As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.
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 Associate 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
6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory 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.
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How you will contribute:
Develop and implement regulatory strategies for new drugs
Guide teams through the drug development processes
Manage complex submissions for biologic licensing
Lead teams effectively, fostering a collaborative environment
Engage with government bodies to facilitate swift approval processes
Analyze and resolve complex regulatory issues
Communicate effectively with various stakeholders
Manage multiple projects simultaneously
Mentor junior staff, providing guidance and support
Innovate regulatory processes to improve internal standards
Skills and qualifications:
Develops and implements regulatory strategies for new drugs, applying advanced understanding of regulatory requirements
Guides teams through the drug development processes with a comprehensive knowledge of pharmaceutical and medical device regulations
Manages complex submissions for biologic licensing, demonstrating in-depth expertise in regulatory guidelines
Leads teams effectively, fostering a collaborative environment and focusing on skill development and professional growth
Engages with government bodies to facilitate swift approval processes, leveraging strong negotiation and communication skills
Analyzes and resolves complex regulatory issues, using critical thinking to maintain compliance and advance business objectives
Communicates effectively with various stakeholders, ensuring clarity and alignment on regulatory matters
Manages multiple projects simultaneously, prioritizing tasks to meet deadlines and organizational goals
Mentors junior staff, providing guidance and support to enhance team capabilities
Innovates regulatory processes, contributing to the improvement of internal standards and practices
As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.
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 Associate 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
6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory 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.
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