Talent.com
Associate Director, Global Regulatory Affairs - GI & Inflammation

Associate Director, Global Regulatory Affairs - GI & Inflammation

TakedaBoston, MA, United States
30+ days ago
Job type
  • Full-time
Job description

Job Description

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.
  • Education & Competencies :

  • 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.

    Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location : Boston, MA

    U.S. Base Salary Range : $153,600.00 - $241,340.00

    The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

    U.S. based employees may be eligible for short-term and / or long-term incentives. U.S.-based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.-based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

    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, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Job Exempt

    Yes

    #J-18808-Ljbffr

    Create a job alert for this search

    Associate Regulatory • Boston, MA, United States

    Related jobs
    • Promoted
    Associate Director, Regulatory Affairs Operations

    Associate Director, Regulatory Affairs Operations

    Kura OncologyBoston, MA, United States
    Full-time
    Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to b...Show moreLast updated: 27 days ago
    • Promoted
    Associate Director, Global Regulatory Affairs, Advertising and Promotion

    Associate Director, Global Regulatory Affairs, Advertising and Promotion

    Takeda PharmaceuticalsBoston, MA, United States
    Full-time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...Show moreLast updated: 30+ days ago
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Rhythm PharmaceuticalsBoston, MA, US
    Full-time
    Quick Apply
    Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases.We develo...Show moreLast updated: 30+ days ago
    Takeda is hiring : Associate Director, Global Regulatory Affairs, Advertising and

    Takeda is hiring : Associate Director, Global Regulatory Affairs, Advertising and

    MediabistroBoston, MA, United States
    Full-time
    Associate Director, Global Regulatory Affairs, Advertising and Promotion.Associate Director, Global Regulatory Affairs, Advertising and Promotion. This role involves managing programs / products as th...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Associate Director, Downstream Process Development

    Associate Director, Downstream Process Development

    EPM ScientificBoston, MA, United States
    Full-time
    We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate Director of Downstream Process Development. This individual will oversee a team of ...Show moreLast updated: 21 hours ago
    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD J

    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD J

    MediabistroBoston, MA, United States
    Full-time
    About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees...Show moreLast updated: 20 days ago
    • Promoted
    Director, Global Regulatory Lead, GI & Inflammation

    Director, Global Regulatory Lead, GI & Inflammation

    TakedaBoston, MA, United States
    Full-time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    United TherapeuticsBoston, MA, United States
    Full-time
    We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.Our public benefit purpose is to provide a brighter future for patients through t...Show moreLast updated: 5 days ago
    Sanofi (US) is hiring : Associate Director, Global Regulatory Affairs Advertising

    Sanofi (US) is hiring : Associate Director, Global Regulatory Affairs Advertising

    MediabistroCambridge, MA, United States
    Full-time
    Associate Director, Global Regulatory Affairs Advertising and Promotion.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for ...Show moreLast updated: 3 days ago
    • Promoted
    Associate Director / Director, Technology Transfer

    Associate Director / Director, Technology Transfer

    AsimovBoston, MA, United States
    Full-time
    Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––f...Show moreLast updated: 1 day ago
    • Promoted
    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD

    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD

    Chiesi GroupBoston, MA, United States
    Full-time
    Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi G...Show moreLast updated: 20 days ago
    • Promoted
    Associate Director / Director, Regulatory CMC

    Associate Director / Director, Regulatory CMC

    CRISPR TherapeuticsBoston, MA, United States
    Full-time
    This position is a key leadership role for the development of the In Vivo franchise at CRISPR.Reporting to the Head of Regulatory Affairs CMC, you will work closely with cross-functional teams and ...Show moreLast updated: 11 days ago
    • Promoted
    Associate Director, CMC Regulatory Affairs, Biologics (Boston, MA)

    Associate Director, CMC Regulatory Affairs, Biologics (Boston, MA)

    Vertex Pharmaceuticals (San Diego) LLCBoston, MA, United States
    Full-time
    Associate Director, CMC Regulatory Affairs, Biologics (Boston, MA) page is loaded## Associate Director, CMC Regulatory Affairs, Biologics (Boston, MA)locations : Boston, MAtime type : Full timepo...Show moreLast updated: 17 days ago
    • Promoted
    Associate Director, Global Regulatory Affairs, Advertising and Promotion

    Associate Director, Global Regulatory Affairs, Advertising and Promotion

    TakedaBoston, MA, United States
    Full-time
    Associate Director, Global Regulatory Affairs, Advertising and Promotion.Associate Director, Global Regulatory Affairs, Advertising and Promotion. This role involves managing programs / products as th...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Compliance Director

    Regulatory Compliance Director

    Dana-Farber Cancer InstituteBrookline, MA, United States
    Full-time
    Regulatory Compliance Director.Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and preven...Show moreLast updated: 30+ days ago
    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD

    Associate Director, Regulatory Affairs Advertising and Promotion Americas, GRD

    MediabistroBoston, MA, United States
    Full-time
    About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years’ experience, operating in 30 countries with more than 6,000 employees ...Show moreLast updated: 19 days ago
    Associate Director, Global Regulatory Affairs, Advertising and Promotion Job at

    Associate Director, Global Regulatory Affairs, Advertising and Promotion Job at

    MediabistroBoston, MA, United States
    Full-time
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Global Regulatory Affairs - GI & Inflammation

    Associate Director, Global Regulatory Affairs - GI & Inflammation

    TakedaBoston, MA, United States
    Full-time
    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 ad...Show moreLast updated: 3 days ago
    • Promoted
    Associate Director, Global Regulatory Affairs, Oncology

    Associate Director, Global Regulatory Affairs, Oncology

    Gilead Sciences, Inc., MA, United States
    Full-time
    Senior Manager, Global Regulatory Affairs, Oncology.United Kingdom - Cambridge Regulatory Regular.Global Therapeutic Area (TA) Regulatory Liaisons. You will act as the Regional Regulatory Lead on mo...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Olema OncologyBoston, MA, United States
    Full-time
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology.Reports to the Senior Vice President of Regulatory Affairs. Location : Boston, MA or San Francisco, CA.Domestic...Show moreLast updated: 9 days ago