BioSpace
Senior Director, Global Regulatory Lead, GI & Inflammation
BioSpace, Boston, Massachusetts, us, 02298
Senior Director, Global Regulatory Lead, GI & Inflammation
Overview Senior Director, Global Regulatory Lead responsible for defining, developing and leading global regulatory strategies to maximize success across complex and multi-project programs in GI & Inflammation. Provides strategic and tactical regulatory guidance, influences cross-functional teams, and leads global regulatory strategy execution in collaboration with regional counterparts. Responsibilities
Define strategies and provide tactical guidance to global regulatory teams and sub-working groups to ensure timely and compliant global regulatory submissions and maintenance of programs. Lead and/or influence cross-functional initiatives within R&D and beyond, mentoring global regulatory leads and ensuring alignment with program objectives. Manage and develop global regulatory teams (GRTs) and sub-working groups (e.g., Label Working Group); represent GRTs at project team meetings. Ensure global regulatory strategies are implemented and adapted to evolving regulatory and business needs; communicate developments to colleagues and stakeholders in a timely, professional manner. Proactively identify regulatory risks, develop solutions, and discuss mitigation strategies with the team and management; assess probabilities of technical success for proposed solutions. Accountable for US FDA submissions and approvals within the scope of responsibility or oversee staff responsible for submissions; lead all submission types as required. Serve as the primary point of contact with health authorities; lead FDA meetings or other regional health authority meetings as appropriate; manage direct reports as needed. Collaborate with regional regulatory leads, other functions, and vendors to ensure global submissions comply with local regulations and maintain product compliance. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participate in or lead departmental and cross-functional task forces and initiatives; contribute to due diligence for licensing opportunities. Partner with global market access colleagues to lead interactions with regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable. Monitor and anticipate regulatory and access trends to strengthen development plans and timely regulatory strategies. Demonstrate Takeda leadership behaviors in all activities. Education & Competencies (Technical And Behavioral)
Bachelor’s Degree in a scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred. 12+ years of pharmaceutical industry experience, including 10 years of regulatory experience or a combination of 8+ years regulatory and/or related experience. Experience reviewing, authoring, or managing components of regulatory submissions. Expert knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW and post-marketing regulatory environments is a plus. Ability to interpret complex scientific issues related to regulatory requirements and strategy across multiple projects. Strong oral and written communication, time management, negotiation skills, integrity, and adaptability. Ability to work effectively with global teams; capable of bringing working teams together to achieve objectives; independent regulatory strategy thinking and problem solving including risk mitigation. Locations & Employment Type
Location: Boston, MA Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. EEO Statement
Takeda is committed 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 protected characteristics in accordance with applicable laws. Note
Locations, compensation ranges, and other benefits stated are subject to change and may vary by location and experience.
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Overview Senior Director, Global Regulatory Lead responsible for defining, developing and leading global regulatory strategies to maximize success across complex and multi-project programs in GI & Inflammation. Provides strategic and tactical regulatory guidance, influences cross-functional teams, and leads global regulatory strategy execution in collaboration with regional counterparts. Responsibilities
Define strategies and provide tactical guidance to global regulatory teams and sub-working groups to ensure timely and compliant global regulatory submissions and maintenance of programs. Lead and/or influence cross-functional initiatives within R&D and beyond, mentoring global regulatory leads and ensuring alignment with program objectives. Manage and develop global regulatory teams (GRTs) and sub-working groups (e.g., Label Working Group); represent GRTs at project team meetings. Ensure global regulatory strategies are implemented and adapted to evolving regulatory and business needs; communicate developments to colleagues and stakeholders in a timely, professional manner. Proactively identify regulatory risks, develop solutions, and discuss mitigation strategies with the team and management; assess probabilities of technical success for proposed solutions. Accountable for US FDA submissions and approvals within the scope of responsibility or oversee staff responsible for submissions; lead all submission types as required. Serve as the primary point of contact with health authorities; lead FDA meetings or other regional health authority meetings as appropriate; manage direct reports as needed. Collaborate with regional regulatory leads, other functions, and vendors to ensure global submissions comply with local regulations and maintain product compliance. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participate in or lead departmental and cross-functional task forces and initiatives; contribute to due diligence for licensing opportunities. Partner with global market access colleagues to lead interactions with regulatory/health agency/HTA bodies on product-specific value evidence topics, as applicable. Monitor and anticipate regulatory and access trends to strengthen development plans and timely regulatory strategies. Demonstrate Takeda leadership behaviors in all activities. Education & Competencies (Technical And Behavioral)
Bachelor’s Degree in a scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred. 12+ years of pharmaceutical industry experience, including 10 years of regulatory experience or a combination of 8+ years regulatory and/or related experience. Experience reviewing, authoring, or managing components of regulatory submissions. Expert knowledge of drug development process and regulatory requirements; knowledge of FDA, EU, Canada, ROW and post-marketing regulatory environments is a plus. Ability to interpret complex scientific issues related to regulatory requirements and strategy across multiple projects. Strong oral and written communication, time management, negotiation skills, integrity, and adaptability. Ability to work effectively with global teams; capable of bringing working teams together to achieve objectives; independent regulatory strategy thinking and problem solving including risk mitigation. Locations & Employment Type
Location: Boston, MA Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. EEO Statement
Takeda is committed 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 protected characteristics in accordance with applicable laws. Note
Locations, compensation ranges, and other benefits stated are subject to change and may vary by location and experience.
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