Senior Regulatory Affairs Expert, Labeling Compliance Specialist

2 days ago

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

The 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 product amendments, while maintaining the currency of product licenses and permits.

Main Responsibilities:

  • This Senior Regulatory Affairs Expert will be responsible for strategic and operational activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs.
  • Partnering with internal stakeholders and external CRO partners such as Global Regulatory Compliance, Global Labeling, IT, Global Regulatory Operations, GPSE (safety), Regulatory Therapeutic Areas, Local Operating Companies and Supply Chain on all matters related to global labeling compliance and quality.
  • Collaborating with the Director of Global Labeling Compliance to ensure successful labeling compliance and quality management, end-to-end tracking of global labeling updates, and implementation of Global Labeling processes.
  • As a key member of the growing Global Labeling Compliance organization, this expert will contribute to setting the direction for the team within Takeda, identifying and attracting top talent to the organization, and strategizing the future of the organization with the Director of Labeling Compliance and others.

Key Accountabilities:

  • Collaborating with Global Labeling leadership to ensure clear and timely communication about labeling compliance activities and metrics.
  • Responsible for alignment with global strategic initiatives related to labeling events and the processes and systems used to manage labeling compliance.
  • Development and leadership of labeling compliance-relevant strategic initiative activities which may impact labeling compliance and labeling processes (labeling event management systems, RIM systems, and quality documents).
  • Working closely with Global Labeling Operations to develop new and updated processes for labeling and labeling compliance, as required.
  • Ensuring Takeda's alignment and responsiveness to external guidelines and regulations as they pertain to applicable regulatory requirements.
  • Providing Global Labeling Compliance support for internal and external audits:
    • Ensures inspection readiness
    • Coordinates Global labeling documentation requests prior to, during and in follow up to inspections/audits
    • Supports Global Labeling SMEs on presentations related to global labeling processes for inspections and audits
    • Presents on global and regional labeling processes and quality to inspectors and auditors
    • Supports the development of responses and CAPAs related to global labeling for audits/inspections
    • Provides regulatory and technical expertise to manage the regulatory inspection preparation and execution processes, including development of related tools and best practices
    • Guarantees a state of readiness for Health Authority inspections within Global Labeling and supporting local country (LOC) activities, including the development of strategic internal audit plans, and the execution of internal audits
  • Ensuring Labeling Commitments to partners and third parties are documented and tracked in the appropriate repository.
  • Escalating issues/problems to senior management as needed.
  • Providing input on budgets for the group as appropriate.
  • Maintaining strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory Affairs and labeling.
  • Representing Takeda at relevant Industry Forums e.g., LabelNet.

Requirements and Skills:

  • Bachelor's degree (or equivalent) required. Masters preferred.
  • 8 plus years in pharmaceutical industry, with good exposure to Regulatory Affairs, labeling, quality assurance, and/or compliance.
  • Familiarity with inspections and audit procedures.
  • Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively manage the interactions necessary for achieving business goals and objectives.
  • Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
  • Demonstrated knowledge of global health authorities, regulations, product approval, labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
  • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
  • Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
  • Excellent analytical, technical, and problem-solving skills (TQM or Six Sigma experience preferred).
  • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
  • Personnel management experience.
  • Project Management abilities.

Salary Range: $120,000 - $180,000 per annum.

  • Regulatory Affairs Compliance Specialist

    1 week ago

    Étreux, Hauts-de-France, United States Meet Full time

    Job DescriptionMeet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.Responsibilities:Collaborate with regulatory teams...

  • Regulatory Compliance Lead for Global Labeling Initiatives

    2 days ago

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

    Job Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...

  • Associate Director, Regulatory Affairs Lead

    1 day ago

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

    About Our CompanyWe are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.Job SummaryThe Associate Director, Global Labeling Lead will oversee the development...

  • Regulatory Affairs Director

    3 days ago

    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...

  • Senior Pharmacovigilance Director, Regulatory Compliance Expert

    4 days ago

    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...

  • Regulatory Affairs Director

    6 days ago

    Étreux, Hauts-de-France, United States Revvity Full time

    Job Title: Regulatory Affairs Director - AmericasAbout the Role:Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from...

  • Regulatory Affairs Director

    2 days ago

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

    **Job Description:**We are seeking an experienced Regulatory Affairs Director 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...

  • Regulatory Affairs Director for Medical Devices

    4 days ago

    Étreux, Hauts-de-France, United States Proclinical Staffing Full time

    Medical Device Regulatory Expert WantedWe are seeking a seasoned Regulatory Affairs Manager to join our team in Boston, MA. This role is crucial for ensuring our medical devices meet all regulatory requirements and standards.About the RoleThis is an exciting opportunity for a hands-on professional with a strong background in medical devices, particularly...

  • Lead Regulatory Expert

    2 days ago

    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...

  • Biotechnology Regulatory Affairs Executive

    7 days ago

    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...

  • Global Regulatory Affairs Transformation Leader

    2 days ago

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

    Transformative Leadership OpportunityTakeda Pharmaceutical is seeking an exceptional Global Regulatory Affairs Transformation Leader to spearhead the development of a best-in-class Regulatory Operations organization.The successful candidate will be responsible for envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...

  • Senior Communications Specialist for Regulatory Compliance

    6 days ago

    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,...

  • Regulatory Affairs Specialist

    5 days ago

    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.

  • Regulatory Affairs Strategist

    3 days ago

    Étreux, Hauts-de-France, United States Meet Full time

    Position OverviewWe are seeking a highly experienced Regulatory Affairs Strategist to drive regulatory strategy for our anti-infective portfolio through all development phases.This role involves co-leading a US NDA with a cross-functional project team and serving as the primary liaison with the FDA. The ideal candidate will have strong communication,...

  • Global Labeling Specialist

    2 days ago

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

    About UsTakeda Pharmaceutical is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices.Job DescriptionThe Associate Director, Global Labeling Lead will be responsible for the development...

  • Regulatory Compliance Specialist

    7 days ago

    Étreux, Hauts-de-France, United States Fiducient Advisors Full time

    About the RoleFiducient Advisors, a leading investment consulting firm, is seeking an experienced Regulatory Compliance Specialist to join its team.The successful candidate will be responsible for ensuring the firm's compliance with applicable regulatory requirements, collaborating with the Compliance Manager on initiatives that drive new efficiencies, and...

  • Global Regulatory Operations Visionary

    1 day ago

    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...

  • Regulatory Compliance Specialist

    6 days ago

    Étreux, Hauts-de-France, United States TechnoGen Full time

    About the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Boston, MA.The ideal candidate will have a strong background in regulatory compliance and a passion for ensuring that our business activities align with applicable laws and regulations.

  • Regulatory Compliance Expert

    2 days ago

    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...

  • Senior Regulatory Expert

    2 days ago

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

    Pharmaceutical Technical Leadership RoleThis 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...