Director, Regulatory Data Office Leader
Vor 7 Stunden
Allschwil, Basel-Landschaft, Schweiz
8542-Actelion Pharmaceuticals Ltd Legal Entity
Vollzeit
Kostenlos per E-Mail oder Google
Speichern Sie diesen Job und halten Sie Ihre Suche organisiert
Erstellen Sie ein kostenloses Konto, um Jobs zu speichern, Benachrichtigungen zu erstellen und von Ihrem Dashboard aus zu diesem Eintrag zurückzukehren.
Kostenlos per E-Mail oder Google
Wenn Sie fortfahren, akzeptieren Sie unsere Nutzungsbedingungen & Datenschutzerklärung.
At Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.
Learn more at jnj.com. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration Job Category: People Leader All Job Posting Locations: Allschwil, Basel-Country, Switzerland
Job Description
About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Website Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States
- Requisition Number: R
- United Kingdom
- Requisition Number: R
- Belgium, Netherlands
- Requisition Number: R
- Switzerland
- Requisition Number: R
- Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson Johnson Innovative Medicine RD is recruiting for a Director, Regulatory Data Office Leader. This position is a hybrid role and will be located in Allschwil, Switzerland. Global Regulatory Affairs (GRA) is seeking an experienced leader with deep regulatory domain expertise and a strong track record in data stewardship and governance. The Director, Regulatory Data Office Leader, will lead a global team of data stewards and oversee the Regulatory Data Hub (RDH), ensuring trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making as we build a world-class regulatory operations organization. As the business owner of GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards, the Director will strengthen the quality, integrity, accessibility, and responsible use of GRA data. This highly collaborative and technically fluent leader will partner across RD, Johnson Johnson Technology (IT), Data, Data Science and Artificial Intelligence (DDSAI), and the enterprise to establish governance policies and standards and to embed trusted data into major transformation efforts. This will include end-to-end Regulatory Information Management (RIM) through the Unified Regulatory Platform (URP), RD Digital Solutions Initiative (i.e. MDM), eLabeling and submission-excellence AI tooling. Regulatory Knowledge and Process Excellence (RKPE) operates through three integrated pillars
- the Data Office, the Process Office, and Decision Enablement. As leader of the Data Office, the Director will be accountable not only for the performance of their own pillar but for actively creating synergy across all three, ensuring that trusted data, well-designed process, and decision enablement operates as one connected capability rather than three separate functions.
Principal ResponsibilitiesData Governance and Stewardship: Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data. Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making. Establish and maintain data governance policy, standards, definitions, and business rules for regulatory data across systems, in close alignment with RD, Pharma, and cross-sector initiatives. Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR). Enable Data Stewards and Domain Owners to establish and monitor regulatory data quality metrics, lead root-cause analysis, prioritize remediation, and measure sustained improvement across regulatory data domains.
Data Council and Framework Leadership: Operate and chair the cross-fu
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.
Learn more at jnj.com. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration Job Category: People Leader All Job Posting Locations: Allschwil, Basel-Country, Switzerland
Job Description
About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Website Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States
- Requisition Number: R
- United Kingdom
- Requisition Number: R
- Belgium, Netherlands
- Requisition Number: R
- Switzerland
- Requisition Number: R
- Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson Johnson Innovative Medicine RD is recruiting for a Director, Regulatory Data Office Leader. This position is a hybrid role and will be located in Allschwil, Switzerland. Global Regulatory Affairs (GRA) is seeking an experienced leader with deep regulatory domain expertise and a strong track record in data stewardship and governance. The Director, Regulatory Data Office Leader, will lead a global team of data stewards and oversee the Regulatory Data Hub (RDH), ensuring trusted, high-quality regulatory data enables business intelligence, analytics, and informed decision-making as we build a world-class regulatory operations organization. As the business owner of GRA data governance capabilities, including the Regulatory Data Council, Regulatory Data Hub, data stewardship program, and regulatory data standards, the Director will strengthen the quality, integrity, accessibility, and responsible use of GRA data. This highly collaborative and technically fluent leader will partner across RD, Johnson Johnson Technology (IT), Data, Data Science and Artificial Intelligence (DDSAI), and the enterprise to establish governance policies and standards and to embed trusted data into major transformation efforts. This will include end-to-end Regulatory Information Management (RIM) through the Unified Regulatory Platform (URP), RD Digital Solutions Initiative (i.e. MDM), eLabeling and submission-excellence AI tooling. Regulatory Knowledge and Process Excellence (RKPE) operates through three integrated pillars
- the Data Office, the Process Office, and Decision Enablement. As leader of the Data Office, the Director will be accountable not only for the performance of their own pillar but for actively creating synergy across all three, ensuring that trusted data, well-designed process, and decision enablement operates as one connected capability rather than three separate functions.
Principal ResponsibilitiesData Governance and Stewardship: Serve as the advocate for regulatory data integrity, ensuring business relevance, quality, trustworthiness, and responsible stewardship of GRA data. Promote shared responsibility and clear accountability for regulatory data ownership, stewardship, quality, access, and decision rights, enabling enterprise-wide insights, analytics, and decision-making. Establish and maintain data governance policy, standards, definitions, and business rules for regulatory data across systems, in close alignment with RD, Pharma, and cross-sector initiatives. Oversee regulatory data ownership and stewardship, ensuring accuracy, consistency, and compliance with global health authority requirements (e.g., IDMP, xEVMPD, SPOR). Enable Data Stewards and Domain Owners to establish and monitor regulatory data quality metrics, lead root-cause analysis, prioritize remediation, and measure sustained improvement across regulatory data domains.
Data Council and Framework Leadership: Operate and chair the cross-fu