Talent.com
Regulatory Intelligence Lead
Regulatory Intelligence LeadMassachusetts Staffing • Lexington, MA, US
Regulatory Intelligence Lead

Regulatory Intelligence Lead

Massachusetts Staffing • Lexington, MA, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Global Regulatory Intelligence Lead

Join us as our Global Regulatory Intelligence Lead and play a pivotal role in the governance, quality oversight, and optimization of Takeda's global processes for Regulatory Intelligence. You will ensure alignment with regulatory expectations and industry best practices, fostering strategic partnerships to enable effective implementation and scalability of these processes. We are seeking an experienced visionary leader to shape and execute our Regulatory Intelligence Roadmap, driving innovation and operational excellence across global regulatory functions.

How You Will Contribute :

  • Drive compliance, operational sustainability, and continuous improvement across Takeda's global operating structure.
  • Define and deliver strategic goals in line with Takeda vision leveraging AI technologies to enhance regulatory insights.
  • Monitor metrics and collect feedback to assess process health and performance.
  • Oversee the management of Regulatory Intelligence surveillance, communication, and compliance.
  • Engage with senior management to gain endorsement of Regulatory Intelligence initiatives.
  • Partner with business and IT system owners to maintain global digital solutions and enhance automation.
  • Lead cross-functional collaborations to accomplish objectives.
  • Support the wider Market Surveillance Team with ad hoc activities.

What You Bring to Takeda :

  • Scientific or engineering graduate (BSc, MSc, PhD) with over 10 years of managerial experience.
  • Proven experience in pharmaceutical manufacturing support and governance.
  • Strong focus on delivering global results and building effective governance.
  • Fluent in written and spoken English.
  • Proven experience in sharpening company's Regulatory Intelligence Roadmap, driving innovation and operational excellence across global regulatory functions.
  • Strong scientific and technical expertise for robust analysis of complex product data.
  • More About Us :

    At Takeda, we are committed to delivering high-quality products to patients worldwide. We strive for excellence in everything we do, fostering a culture of innovation and continuous improvement. Join us and contribute to our mission of improving health and well-being through leading-edge science and technology.

    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 : Lexington, 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 : Lexington, 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. An employer who violates this law shall be subject to criminal penalties and civil liability.

    [job_alerts.create_a_job]

    Regulatory Lead • Lexington, MA, US

    [internal_linking.related_jobs]
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Deciphera Pharmaceuticals • Waltham, MA, US
    [job_card.full_time]
    We are seeking a dynamic and strategic .Associate Director, Regulatory Affairs.The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Regulatory Affairs

    Director, Regulatory Affairs

    Crescent Biopharma, Inc. • Waltham, MA, US
    [job_card.full_time]
    Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Regulatory Operations

    Associate Director, Regulatory Operations

    Crescent Biopharma, Inc. • Waltham, MA, US
    [job_card.full_time]
    Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Specialist

    Regulatory Specialist

    Instylla • Bedford, MA, US
    [job_card.full_time]
    We are NOT accepting resumes from recruitment agencies or search firms.Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Manager of Regulatory Affairs

    Manager of Regulatory Affairs

    MedTech Talent Solutions • Bedford, MA, US
    [job_card.permanent]
    Play a key role in shaping global regulatory strategy for innovative surgical technologies.Lead regulatory submissions across multiple markets, supporting meaningful product advancements.Join a hig...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Oncology GRA

    Associate Director, Oncology GRA

    Women In Bio • Waltham, MA, United States
    [job_card.full_time]
    Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    Associate Director, Pharmacovigilance Quality & Compliance (PVQA)

    PharmaEssentia U.S.A. • Burlington, MA, US
    [job_card.full_time]
    It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities.You’ll find that rare opportunity at PharmaEssentia USA.Join us, a...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director Pharmacovigilance

    Senior Director Pharmacovigilance

    Vivid Resourcing • Waltham, MA, US
    [job_card.full_time]
    The Senior Director, Pharmacovigilance Sciences provides strategic leadership and scientific oversight for safety data analysis across both investigational and marketed products.This role leads a h...[show_more]
    [last_updated.last_updated_1_hour] • [promoted] • [new]
    Director, Regulatory Affairs & Quality Assurance - medical device

    Director, Regulatory Affairs & Quality Assurance - medical device

    InnoTech Staffing • Burlington, MA, US
    [job_card.full_time] +1
    InnoTECH Staffing is looking to hire a fulltime permanent Director of Regulatory Affairs & Quality Assurance (RA / QA) for an exciting and growing medical device company in Burlington, MA.Candida...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Assistant Casino Regulatory Manager, Plainville

    Assistant Casino Regulatory Manager, Plainville

    Mass., Inc. • Plainville, MA, United States
    [job_card.full_time]
    The Massachusetts Gaming Commission (MGC) seeks to hire an Assistant Casino Regulatory Manager (ACRM) assigned to the Plainridge Park Casino in Plainville, MA. With guidance from the Casino Regulato...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Lexington Medical, Inc. • Bedford, MA, US
    [job_card.full_time]
    With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving $6B...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Oncology Global Regulatory Affairs Associate Director

    Oncology Global Regulatory Affairs Associate Director

    Women In Bio • Waltham, MA, United States
    [job_card.full_time]
    A global biopharma company is seeking a regulatory professional in Waltham, MA, to lead regional regulatory strategies and collaborate with commercial teams. The ideal candidate has a Bachelor's deg...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Affairs Professional

    Regulatory Affairs Professional

    804 Technology • Newton, MA, US
    [job_card.full_time]
    As a Regulatory Affairs Specialist Consultant, you will be responsible for : .Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US marke...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Risk Governance Lead

    Risk Governance Lead

    Insight Global • Waltham, MA, United States
    [job_card.full_time] +1
    Be among the first 25 applicants.This range is provided by Insight Global.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Hybrid in Waltham, MA ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Regulatory Compliance Paralegal

    Regulatory Compliance Paralegal

    KabaFusion • Lexington, MA, US
    [job_card.full_time]
    Come join an exciting and innovative company that puts the “care” back in healthcare!.At KabaFusion, our patients come from all walks of life and so do we. We hire GREAT people, period! ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director Regulatory Affairs

    Associate Director Regulatory Affairs

    EPM Scientific • Bedford, MA, US
    [job_card.full_time]
    Associate Director of Regulatory Strategy.A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented.Associate Director of Regu...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Regulatory CMC

    Senior Director, Regulatory CMC

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    [job_card.full_time]
    The Senior Director, Regulatory CMC will lead and evolve Apellis's global Chemistry, Manufacturing, and Controls (CMC) strategies to support the company's innovative therapeutic pipeline and market...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    OSI Systems • North Billerica, MA, US
    [job_card.full_time]
    Rapiscan, an OSI Systems Company is seeking a Regulatory Affairs Specialist based out of Billerica, MA.Rapiscan Systems, an OSI Systems, Inc. Our products are used to inspect baggage, cargo, people,...[show_more]
    [last_updated.last_updated_30] • [promoted]