Aktuelle Jobs im Zusammenhang mit Regulatory Submission Coordinator - Penzberg, Bayern - Roche
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Regulatory Submission Specialist
vor 3 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitJob SummaryThe Regulatory Submission Manager is responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role involves editing complex technical documents, managing submission projects, and applying submission management skills to contribute to the daily business of Pharma Technical Regulatory submissions.Key...
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Regulatory Submission Specialist
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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 skilled professional with expertise in editing complex technical documents, managing regulatory information management systems, and coordinating submission management...
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Regulatory Submission Specialist
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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 skilled professional with expertise in editing complex technical documents, managing regulatory information management systems, and coordinating submission management...
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Submission Manager
vor 2 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitJob SummaryThe Submission Manager plays a crucial role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires strong technical document editing skills, regulatory knowledge, and excellent communication abilities.Key ResponsibilitiesEdit complex technical documents for clarity, grammar, spelling, and...
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Submission Manager
vor 2 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitJob SummaryThe Regulatory Submission Manager at Roche is responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role involves editing complex technical documents, managing the flow of information, and ensuring data accuracy and quality.Key ResponsibilitiesEdit complex technical documents for clarity, grammar,...
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Submission Manager
vor 4 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitAbout the RoleThe Submission Manager is a key member of our Regulatory Affairs team, responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role requires strong editing skills, attention to detail, and the ability to work with complex technical documents.Key ResponsibilitiesEdit complex technical documents for...
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Submission Manager
vor 4 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitAbout the RoleThe Submission Manager is a key member of our Regulatory Affairs team, responsible for delivering high-quality regulatory submissions to Health Authorities worldwide. This role requires strong editing skills, attention to detail, and the ability to work with complex technical documents.Key ResponsibilitiesEdit complex technical documents for...
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Submission Manager
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitJob Title: Submission ManagerAbout the Role:The Submission Manager plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires strong editing skills, attention to detail, and the ability to manage complex technical documents.Key Responsibilities:Edit complex technical documents for clarity,...
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Submission Manager
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitJob Title: Submission ManagerAbout the Role:The Submission Manager plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires strong editing skills, attention to detail, and the ability to manage complex technical documents.Key Responsibilities:Edit complex technical documents for clarity,...
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Regulatory Content Coordinator
vor 1 Monat
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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,...
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Regulatory Content Coordinator
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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,...
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Submission Manager
vor 3 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitAbout the RoleThe Submission Manager plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires strong editing skills, attention to detail, and the ability to manage complex technical documents.Key ResponsibilitiesEdit complex technical documents for clarity, grammar, spelling, and...
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Submission Manager
vor 3 Wochen
Penzberg, Bayern, Deutschland Roche VollzeitAbout the RoleThe Submission Manager plays a critical role in delivering high-quality regulatory submissions to Health Authorities worldwide. This position requires strong editing skills, attention to detail, and the ability to manage complex technical documents.Key ResponsibilitiesEdit complex technical documents for clarity, grammar, spelling, and...
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Regulatory Document Specialist
vor 1 Monat
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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,...
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Regulatory Document Specialist
vor 2 Monaten
Penzberg, Bayern, Deutschland Roche VollzeitAbout 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,...
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Submission Manager
vor 5 Monaten
Penzberg, Deutschland Roche VollzeitThe Position The Submission Manager delivers high quality regulatory submissions to Health Authorities worldwide. They edit complex technical documents. They have responsibilities for varying regulatory submission projects, as business needs dictate. They apply submission management skills to their work and contribute to the daily business of Pharma...
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Regulatory & Ethics Committee Submission
vor 5 Monaten
Penzberg, Deutschland Franz & Wach Personalservice GmbH Vollzeit**Your tasks at Roche Diagnostics**: - Reviews and adapts documents and templates relevant for submission - Compiles submission packages - is the first point of contact for queries from the Ethics Committee and the authority - prepares and submits the answers to queries - Oversight of CRO/CRA activities **The requirements**: - Bachelor /Masters Degree in...
Regulatory Submission Coordinator
vor 3 Monaten
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 submission management to contribute effectively to the daily operations of Pharma Technical Regulatory submissions, demonstrating the ability to handle all submission types across international Health Authorities.
Key Responsibilities:
- Edit intricate technical documents for clarity, grammar, spelling, and punctuation, ensuring compliance with relevant regulatory guidelines and Roche standards.
- Oversee the information flow and data entry into the regulatory information management system, ensuring accuracy and maintaining high data quality.
- Provide support and coordination in the preparation of new and existing regulatory applications, adhering to health authority regulations.
- Act as a vital member of local filing teams, offering ongoing expertise regarding regulatory submissions and guidance on compliance and timelines.
- Facilitate communication and collaboration to meet submission deadlines and plan for future requirements.
- Manage document flow via document-sharing systems and ensure version control throughout the submission process.
- Liaise with technical subject-matter experts to ensure timely delivery of content and provide regular status updates.
- Coordinate training on documentation systems and tools, collecting relevant submission-related data.
- Facilitate submission reviews and adjudication meetings, performing live editing to capture stakeholder decisions.
- Collaborate with internal partners, including Regulatory Publishing and Project Management.
- Provide input on future system enhancements and updates to business processes.
Additional Duties:
- Promote knowledge sharing and best practice workshops to foster continuous improvement.
- Lead or actively participate in teams for special or ongoing initiatives and projects.
- Support the development and implementation of new or updated systems, processes, or tools.
- Assist in user acceptance testing for new or updated systems or electronic tools.
- Willingness to travel and work internationally as required.
Quality Assurance Responsibilities:
- Stay informed about internal and external developments, trends, and dynamics relevant to Pharma Technical Regulatory work.
- Contribute to the development and maintenance of policies and Standard Operating Procedures.
- Ensure compliance with Roche standards and guidelines for eCTD submissions.
- Adhere to regulations and company policies, following all Roche Standard Operating Procedures.
- Maintain a mindset focused on continuous improvement, identifying opportunities to streamline processes.
Required Qualifications:
- A minimum of a BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field.
- Proficiency in Regulatory Information Management systems is preferred but not mandatory.
- A strong background in editing, with at least three years of professional experience in a scientific or technical field preferred.
- Previous experience with regulatory documents in CTD structure and guidelines from ICH, FDA, and EMA is beneficial.
- Expert-level proficiency in Word, Excel, PowerPoint, and Adobe Acrobat, along with experience in document management and sharing systems.
- Excellent teamwork skills and the ability to effectively interface with a diverse range of stakeholders.
- Strong organizational and time management skills, with the ability to deliver under pressure.
Competencies and Skills:
- Exceptional written and verbal communication skills.
- Ability to listen well and express ideas clearly, valuing input from others.
- Understanding of different functional perspectives within the organization.
- Strong analytical skills, with the ability to think clearly and logically through problems.
- Effective change management skills, providing context and addressing concerns.
- Proven project management abilities, consistently achieving multiple tasks on time.
- Proactive in managing issues as they arise.
- Recognizes and appreciates the contributions of peers.
- Encourages the exchange of ideas and support among colleagues.
- Capable of aligning team efforts with the mission of Pharma Technical Regulatory.
- Articulates long-term objectives and strategies effectively.
