Senior Regulatory Expert

1 day ago


Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
Pharmaceutical Technical Leadership Role

This leadership position plays a pivotal role in shaping the pharmaceutical industry's regulatory landscape. As a Senior Regulatory Expert, you will lead efforts to define and implement external engagement strategies, governance, and associated capabilities for Takeda Pharmaceutical.

Key Responsibilities:
  • Develop and execute global regulatory CMC strategy, ensuring alignment with patient-centric values.
  • Cultivate relationships with key stakeholders, including regulatory agencies, industry associations, and internal subject matter experts.
  • Influence emerging technical regulations and guidance through collaboration with regulatory agencies and trade associations.
  • Mentor and coach team members to enhance proactive communication of regulatory risks, challenges, and opportunities.
Requirements:
  • Bachelor's or advanced degree in Life Sciences, Pharmacy, Chemistry, Biology, or related field.
  • Languages: Fluent in English (oral and written); additional languages desirable.
  • Minimum 15-20 years of experience within regulatory agencies or the pharmaceutical industry, including significant leadership experience in Quality/Regulatory/Technical areas.
  • Demonstrated ability to develop creative approaches to problem-solving and adapt to changing priorities or unexpected events.
Compensation and Benefits:

Takeda offers an estimated salary range of $205,100.00 - $322,300.00 per year, depending on qualifications and experience. Additionally, eligible employees may participate in short-term and long-term incentives, medical, dental, vision insurance, 401(k) plan, and company match.

About Takeda Pharmaceutical:

Takeda is committed to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, citizenship status, or other protected characteristics.



  • Étreux, Hauts-de-France, United States Edgewise Therapeutics Full time

    About Edgewise Therapeutics:Edgewise Therapeutics is a leading biopharmaceutical company focused on developing innovative medicines for serious muscle diseases. Our mission is to improve the lives of patients by harnessing our expertise in muscle biology and biophysics.We are committed to building a strong leadership team with a track record in the...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewThe role of Senior Regulatory Affairs Expert, Labeling Compliance Specialist at Takeda Pharmaceutical is a pivotal position that ensures the company's products meet regulatory requirements and maintain compliance with global labeling standards.This position plays a crucial role in ensuring Takeda gains regulatory approval for new products and...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewAs a Senior Technical Regulatory Advisor at Takeda Pharmaceutical, you will be responsible for defining and implementing an external engagement strategy, governance, and associated capabilities in line with the company's patient-centric values.The role requires strong leadership experience in Quality/Regulatory/Technical areas, with a minimum of...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    **Job Summary:** We are seeking an experienced Lead Regulatory Expert to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success for...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time

    About the RoleWe are seeking a highly skilled Senior Manager to lead our global regulatory efforts in the GI and Inflammation department at Takeda Pharmaceuticals.As a key member of our team, you will oversee and execute all regulatory activities for multiple projects, including one highly complex project in development. Your expertise will be crucial in...


  • Étreux, Hauts-de-France, United States Massachusetts Department of Public Utilities Full time

    Job Description:The Massachusetts Department of Public Utilities seeks a highly skilled Senior Utility Regulatory Counsel to join its team. As a key member of the department's leadership, you will play a critical role in shaping the state's utility regulatory policies.About the Role:The successful candidate will serve as a trusted advisor to the General...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewWe are seeking a highly experienced Strategic Regulatory Expert to join our team at Takeda Pharmaceutical.

  • Regulatory Expert

    2 days ago


    Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Role OverviewWe are seeking a highly skilled Regulatory Expert to join our team in Boston, MA. As a key member of our regulatory department, you will play a critical role in the development and implementation of innovative device and integral/co-packaged combination product regulatory strategies.About UsTakeda Pharmaceutical is a world-class R&D organization...


  • Étreux, Hauts-de-France, United States Cognizant Full time

    Compliance Lead Position OverviewCognizant Technology Solutions seeks a seasoned QEA Compliance Lead with extensive expertise in Quality Engineering and Assurance to oversee the assessment of GxP systems, conduct risk assessments, and ensure compliance with regulatory standards.About CognizantWe're a global leader in digital transformation, serving clients...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    We are a patient-focused company that strives for excellence in everything we do. At Takeda Pharmaceutical, we unlock innovation and deliver transformative therapies to patients worldwide.About the RoleAs a Senior Director, Global Regulatory Lead, GI & Inflammation, you will define, develop, and lead global strategies to maximize regulatory success towards...


  • Étreux, Hauts-de-France, United States MFS Investment Management Full time

    About the RoleMFS Investment Management is seeking a skilled Senior Communications Specialist to join our Global Distribution Communication Oversight Team (GDCOT). This role will be responsible for monitoring and reviewing electronic communications of assigned employees to ensure compliance with FINRA, SEC, and internal guidelines. As a Registered Principal,...


  • Étreux, Hauts-de-France, United States Coverys Full time

    Job OverviewCoverys is a leading insurance company providing innovative solutions to customers across the United States. We are seeking an experienced Regulatory Counsel to join our team, responsible for ensuring compliance with regulatory requirements and providing expert advice on complex insurance matters.


  • Étreux, Hauts-de-France, United States Tomorrow Full time

    We are seeking a seasoned Senior Corporate Attorney to join our dynamic team at Tomorrow.io. As a key member of our organization, you will play a critical role in managing all legal aspects of our business.Key Responsibilities:Provide Strategic Legal Guidance: Serve as an advisor to our management team, providing expert and strategic legal advice to mitigate...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Senior Regulatory Affairs Leadership OpportunityWe are seeking a highly experienced and visionary leader to head our Global Regulatory Operations team at Takeda Pharmaceutical. As a key member of our senior leadership team, you will be responsible for driving the development and implementation of our regulatory strategy, ensuring compliance with global...


  • Étreux, Hauts-de-France, United States Albion Rye Associates Full time

    Albion Rye Associates is seeking a highly experienced Regulatory Affairs professional to lead our regulatory strategy and guide us through key regulatory milestones.The ideal candidate will have a strong background in FDA regulatory submissions, a comprehensive understanding of the biotechnology regulatory landscape, and an established record of working with...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is a global leader in transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled Regulatory Strategy Lead to join our team.This is a senior leadership position that requires expertise in developing and implementing global regulatory...


  • Étreux, Hauts-de-France, United States Fidelity TalentSource LLC Full time

    About the Role">This role is a key part of Fidelity Digital Asset Services, LLC's Compliance team. As a trusted business partner, you will promote a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.You will support regulatory oversight of FDAS, collaborating closely with various teams within FDAS and across the...


  • Étreux, Hauts-de-France, United States STATE STREET CORPORATION Full time

    State Street Corporation, a leading global financial institution, seeks an experienced attorney to support its Americas Investment Services business.About the RoleWe are looking for a highly skilled and motivated attorney to join our team in providing regulatory advice to business colleagues, drafting and reviewing service agreements, and analyzing...


  • Étreux, Hauts-de-France, United States Monte Rosa Therapeutics Full time

    Senior Regulatory Professional for Innovative TherapiesMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.The successful candidate will be responsible for developing and...


  • Étreux, Hauts-de-France, United States MFS Investment Management Full time

    About the RoleWe are seeking a highly skilled Regulatory Lead Specialist to join our team at MFS Investment Management. This role will play a critical part in supporting our attorneys with their work on investment advisory and retail distribution matters, as well as MFS retirement plan and welfare benefit plan matters.Key ResponsibilitiesSupport and take...