Regulatory Submission Specialist

vor 1 Woche

Penzberg, Bayern, Deutschland Roche Vollzeit

About the Role

The Regulatory Submission Manager at Roche plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires a skilled professional with expertise in editing complex technical documents, managing regulatory information management systems, and coordinating submission management processes.

Key Responsibilities

  • Edit complex technical documents for clarity, grammar, spelling, and punctuation, ensuring adherence to applicable regulatory guidelines.
  • Manage the flow of information and input of data into the regulatory information management system, maintaining data accuracy and quality.
  • Support and coordinate the preparation of new and existing regulatory applications, ensuring compliance with health authority regulations.
  • Provide ongoing expertise and guidance on regulatory submissions, compliance, timing, and other relevant matters.
  • Facilitate communication and collaboration to meet submission timelines and plan future requirements.
  • Manage document flow via document-sharing systems and document management systems, ensuring version control throughout the submission generation process.
  • Communicate with technical subject-matter experts to ensure content delivery according to schedule and provide status updates.
  • Coordinate and provide training on documentation systems and tools, collecting relevant submission-related data.
  • Facilitate submission reviews and review adjudication meetings, performing live editing to capture stakeholders' decisions.
  • Collaborate with internal partners, including Regulatory Publishing, Project Management, Business Systems, etc.
  • Provide input on future system enhancements, business process updates, and submission model documents.

Additional Responsibilities

  • Facilitate knowledge sharing and best practice workshops, contributing to continuous improvement.
  • Lead or be an active member of teams for special or ongoing initiatives and projects.
  • Participate in and/or support the development and implementation of new or updated PTR and/or specific systems, processes, or other relevant tools.
  • Support user acceptance testing for new or updated systems or electronic tools.
  • Ability to travel and work internationally.

Quality-Related Job Accountabilities

  • Stay abreast of internal and external developments, trends, and other dynamics relevant to the work of PT and PTR.
  • Contribute to the development and maintenance of policies and/or Standard Operating Procedures and related document management processes.
  • Ensure compliance with Roche standards, ICH, and other guidelines for incorporation into eCTD submissions.
  • Follow regulations and company policies, and comply with all Roche Standard Operating Procedures.
  • Demonstrate a continuous improvement mindset, identifying and recommending opportunities to streamline or improve processes.

Qualifications

  • Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field.
  • Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory.
  • Strong track record as an editor, including at least three years of professional experience, in a scientific or technical field preferred but not mandatory.
  • Previous experience with regulatory documents in CTD structure and other ICH, FDA, and EMA guidelines, and global submission dossiers or in the biotech or pharmaceutical industry is beneficial.
  • Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat, and experience with document management systems and document sharing systems.
  • Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders, including PTR submission leads, scientific subject-matter experts, reviewers at all levels, and colleagues located in other countries.
  • Strong organizational and time management skills and ability to deliver under pressure and work flexibly to support changing assignments and priorities in an independent and reliable manner.

Competencies and Skills

  • Strong written and verbal communication skills.
  • Listens well and expresses ideas fluently and eloquently, is open to the input of others, can be depended on to tell the truth regardless of the circumstances.
  • Understands the perspectives of different functional areas in the organization.
  • Gathers information and thinks through problems clearly and logically, and makes timely decisions.
  • Effectively manages change; explaining the context, answering questions, and patiently listening to concerns.
  • Project management: consistently achieves multiple tasks and goals on-time.
  • Proactively manages issues as, or before, they arise.
  • Recognizes and rewards hard work and dedication to excellence contributions of peers.
  • Fosters an exchange of ideas and support amongst colleagues.
  • Able to help others link and prioritize their work with the mission of PTR and Roche.
  • Articulates long-term objectives and strategies, and is good at promoting an idea or vision.

  • Regulatory Submission Specialist

    vor 1 Monat

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Position Overview The Regulatory Submission Specialist is responsible for ensuring the delivery of high-quality regulatory submissions to health authorities across the globe. This role involves editing intricate technical documents and managing various regulatory submission projects based on business requirements. The specialist applies their expertise...

  • Regulatory Submission Coordinator

    vor 1 Monat

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Position Overview The Regulatory Submission Coordinator is responsible for ensuring the delivery of high-quality regulatory submissions to health authorities across the globe. This role involves editing intricate technical documents and managing various regulatory submission projects based on business requirements. The coordinator applies their...

  • Regulatory Submission Coordinator

    vor 1 Monat

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Position Overview The Regulatory Submission Coordinator is responsible for producing high-quality regulatory submissions to health authorities globally. This role involves editing intricate technical documents and managing various regulatory submission projects as dictated by business needs. The coordinator applies submission management expertise to...

  • Regulatory Submission Coordinator

    vor 1 Monat

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Position Overview The Regulatory Submission Coordinator is responsible for ensuring the delivery of high-quality regulatory submissions to health authorities globally. This role involves editing intricate technical documents and managing various regulatory submission projects based on business requirements. The individual will utilize submission...

  • Regulatory Submission Coordinator

    vor 1 Monat

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Overview of the Role The Regulatory Submission Coordinator is responsible for ensuring the delivery of high-quality regulatory submissions to Health Authorities globally. This role involves editing intricate technical documents and managing various regulatory submission projects as required by business needs. The coordinator applies their expertise in...

  • Regulatory Submission Manager

    vor 2 Wochen

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Job SummaryThe Regulatory Submission Manager will be responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role requires strong technical writing and editing skills, as well as the ability to manage complex regulatory submission projects.Key ResponsibilitiesDocument Editing and Review: Edit complex technical...

  • Regulatory Submission Manager

    vor 2 Wochen

    Penzberg, Bayern, Deutschland Roche Vollzeit

    Job SummaryThe Regulatory Submission Manager will be responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role requires strong technical writing and editing skills, as well as the ability to manage complex regulatory submission projects.Key ResponsibilitiesDocument Editing and Review: Edit complex technical...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    {"h1": "Mitarbeiter Regulatory Affairs (w/m/d) bei Roche in Mannheim"} Wir suchen einen erfahrenen Mitarbeiter Regulatory Affairs (w/m/d) für unseren Kunden Roche in Mannheim. Als Teil unseres Teams werden Sie eine wichtige Rolle bei der Gewährleistung der Einhaltung von Vorschriften und Richtlinien spielen. Ihre Aufgaben: Regulatory Dokumente und...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    {"h1": "Mitarbeiter Regulatory Affairs (w/m/d) bei Roche in Mannheim"} Wir suchen einen erfahrenen Mitarbeiter Regulatory Affairs (w/m/d) für unseren Kunden Roche in Mannheim. Als Teil unseres Teams werden Sie eine wichtige Rolle bei der Gewährleistung der Einhaltung von Vorschriften und Richtlinien spielen. Ihre Aufgaben: Regulatory Dokumente und...

  • Regulatory Document Specialist

    vor 2 Wochen

    Penzberg, Bayern, Deutschland Roche Vollzeit

    About the RoleThe Regulatory Submission Manager at Roche plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires a strong understanding of regulatory requirements and the ability to manage complex technical documents.Key ResponsibilitiesEdit complex technical documents for clarity,...

  • Regulatory Content Coordinator

    vor 2 Wochen

    Penzberg, Bayern, Deutschland Roche Vollzeit

    About the RoleThe Regulatory Submission Manager at Roche plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires a strong understanding of regulatory requirements and the ability to manage complex technical documents.Key ResponsibilitiesEdit complex technical documents for clarity,...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Als Teil des Teams von headwaypersonal GmbH suchen wir einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Regulatory Affairs Manager sind Sie verantwortlich für die Zusammenarbeit mit unseren Kunden und die Gewährleistung, dass alle regulatorischen Anforderungen erfüllt werden. Ihre Aufgaben:Die Erstellung und...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Als Teil des Teams von headwaypersonal GmbH suchen wir einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Regulatory Affairs Manager sind Sie verantwortlich für die Zusammenarbeit mit unseren Kunden und die Gewährleistung, dass alle regulatorischen Anforderungen erfüllt werden. Ihre Aufgaben:Die Erstellung und...

  • Dokumentations- und Submission-Experte

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Wir suchen einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Teil unseres Teams bei headwaypersonal GmbH werden Sie sich auf die Herausforderungen der Regulierungsarbeit konzentrieren und unsere Kunden bei der Umsetzung von Strategien unterstützen. Ihre Aufgaben:Die Erstellung und Übermittlung von...

  • Dokumentations- und Submission-Experte

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Wir suchen einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Teil unseres Teams bei headwaypersonal GmbH werden Sie sich auf die Herausforderungen der Regulierungsarbeit konzentrieren und unsere Kunden bei der Umsetzung von Strategien unterstützen. Ihre Aufgaben:Die Erstellung und Übermittlung von...

  • Regulierungsbeauftragter

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Als Teil des Teams von headwaypersonal GmbH suchen wir einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Regulatory Affairs Manager sind Sie verantwortlich für die Erstellung und Übermittlung von regulatorischen Dokumenten und Submissionen. Sie werden sich mit externen Partnern und Stakeholdern in Verbindung setzen, um...

  • Regulierungsbeauftragter

    vor 2 Wochen

    Penzberg, Bayern, Deutschland headwaypersonal GmbH Vollzeit

    Als Teil des Teams von headwaypersonal GmbH suchen wir einen erfahrenen Regulatory Affairs Manager für unseren Kunden Roche in Mannheim.Als Regulatory Affairs Manager sind Sie verantwortlich für die Erstellung und Übermittlung von regulatorischen Dokumenten und Submissionen. Sie werden sich mit externen Partnern und Stakeholdern in Verbindung setzen, um...

  • Regulatory Compliance Expert

    vor 1 Woche

    Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

    Are you a detail-oriented professional looking for a new challenge in the pharmaceutical industry?We are seeking a Compliance Specialist to join our team at GULP – experts united. As a Compliance Specialist, you will play a critical role in ensuring the quality and integrity of our clinical trial supply management, drug-related distribution, and storage...

  • Regulatory Compliance Expert

    vor 1 Woche

    Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

    Are you a detail-oriented professional looking for a new challenge in the pharmaceutical industry?We are seeking a Compliance Specialist to join our team at GULP – experts united. As a Compliance Specialist, you will play a critical role in ensuring the quality and integrity of our clinical trial supply management, drug-related distribution, and storage...

  • Compliance Specialist

    vor 2 Wochen

    Penzberg, Bayern, Deutschland GULP – experts united Vollzeit

    About GULP – experts unitedWe are a leading provider of expert services in the pharmaceutical industry, and we are seeking a highly skilled Compliance Specialist to join our team.Job SummaryThe Compliance Specialist will be responsible for ensuring the GxP compliance of all activities in the clinical trial supply management, drug-related distribution, and...