- Edit complex technical documents for clarity, grammar, spelling, and punctuation. Ensure adherence to applicable regulatory CTD) and Roche guidelines
- Manage the flow of information and input of data into the regulatory information management system, ensuring data accuracy and maintaining data quality
- Support and provide coordination, compilation and submission management in the preparation of new and existing regulatory applications, in compliance with health authority regulations
- A key member of local filing teams, provide ongoing expertise regarding regulatory submissions and guidance on compliance, timing and other relevant matter
- Facilitates communication and collaboration to meet submission timelines and plan future requirements.
- Manage the flow of documents via document-sharing systems SharePoint) and document management-systems Documentum) and ensure version control throughout the submission generation process (writing, review, and internal approval)
- Communicate with technical subject-matter experts to ensure content is delivered according to schedule and provide status updates.
- Coordinate and provide training on documentation systems and tools and collect relevant submission related data
- Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders' decisions
- Collaborate with internal partners Regulatory Publishing, Project Management, Business Systems, etc.)
- Providing input on future system enhancements, business process updates, and submission model documents
- Facilitate knowledge sharing and best practice workshops contributing to continuous improvement
- Lead or is an active member of teams for special or ongoing initiatives and project
- Participates in and/or otherwise supports development and implementation of new or updated PTR and/or -specific systems, processes, or other relevant tools.
- Includes supporting user acceptance testing for new or updated systems or electronic tools
- Ability to travel and work internationally
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PT and PTR. Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
- Contributes to 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
- Follows regulations and company policies, and complies with all Roche Standard Operating Procedures
- Demonstrates a continuous improvement mindset, with identifying and recommending opportunities to streamline or improve processes
- 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 Documentum) and document sharing systems SharePoint)
- 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
- 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
-
Akkodis Germany Tech Experts GmbH Penzberg, Deutschland GanztagsDu bist auf der Suche nach neuen und spannenden Herausforderungen? Dann beginne Deine Karriere bei uns und werde ein Teil des Teams unseres Kunden, einem renommierten Unternehmen der Pharma/ Diagnostik Branche ab sofort für ein längeres Projekt. · Ort: Penzberg · Start: · Was Si ...
-
IMPACT GmbH - Penzberg Penzberg, DeutschlandRegulatory & Ethics Committee Submission Coordinator (m/w/d) - ROCHE Penzberg · Standort: Penzberg · Anstellungsart(en): Vollzeit · Beschäftigungsbeginn: · Im Rahmen einer Arbeitnehmerüberlassung suchen wir für unseren langjährigen Partner, ROCHE, einen Regulatory & Ethics Commi ...
-
Akkodis Germany Tech Experts GmbH Penzberg, Deutschland GanztagsAkkodis - entstanden durch den Zusammenschluss von AKKA & Modis - ist ein weltweit führendes Unternehmen im Bereich Engineering & IT. Als globaler Partner in einer sich ständig verändernden Technologie- & Wettbewerbsumgebung unterstützen wir unsere Kunden mit unserem 360°-Angebot ...
-
Manager Business Development
vor 3 Wochen
GÖRG Munich, DeutschlandIhre Zukunft – bei GÖRG · GÖRG gehört zu Deutschlands führenden unabhängigen Wirtschaftskanzleien. Unsere Top-Position in allen Bereichen des Wirtschaftsrechts beruht auf der engagierten Zusammenarbeit von rund 350 Anwälten und Steuerberatern (m/w/d), die unsere Mandanten persön ...
-
Senior Regulatory Affairs Associate
vor 4 Wochen
Cpl Life Sciences Munich, DeutschlandJob Title: Senior Regulatory Affairs Officer (Maternity Cover) · Location: Munich, Germany – (Hybrid) · Remuneration: €45,000 - €55,000 · Senior Regulatory Affairs Officer opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescrip ...
-
Biologist (f/m/x)
vor 2 Wochen
Formycon AG Munich, DeutschlandTeam Lead Regulatory Affairs CMC Drug Product (gn) · Manager First Level · Medicine, Pharmacy, Laboratory · Quality Management, Quality Assurance · Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Wit ...
-
Daiichi Sankyo Europe GmbH München, DeutschlandWith over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. · In Europe, we focus on two areas: The goal of ou ...
-
Quality Assurance
vor 3 Wochen
Flavine München, DeutschlandJoin our team in Munich, Germany, and step into the role of QA/RA, where you'll play a pivotal role within our vibrant QA/RA department, with the focus on API. This position isn't just about day-to-day operations; it's about spearheading the enhancement of our QA/RA operational s ...
-
Scrum Master im Bereich Technology
vor 2 Wochen
newboxes GmbH Munich, Deutschland GanztagsOpen up · Du hast keine Lust ein kleines Rädchen im Getriebe zu sein? · Du suchst nach einem coolen und dynamischen Umfeld, in dem Du verantwortungsvolle und abwechslungsreiche Aufgaben übernehmen kannst? · Dann ist newboxes genau das Richtige für Dich · Werde Teil eines ambit ...
-
Senior Director of Statistical Methodology
vor 3 Wochen
AL Solutions Munich, Deutschland GanztagsAramis is partnered with a cutting-edge biopharmaceutical company committed to innovation, research, and development has positioned them as a leader in the industry. With a focus on Infectious Disease and Oncology studies, they are seeking a dynamic and experienced Statistical Me ...
-
Safety Physician
vor 1 Woche
Daiichi Sankyo Europe GmbH München, DeutschlandWith over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. · In Europe, we focus on two areas: The goal of ou ...
-
Clinical Research Associate II
vor 3 Wochen
Allucent Munich, DeutschlandAt AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. · We are looking for a Clinical Research Associate II (CRAII) to jo ...
-
Clinical Research Lead
vor 3 Wochen
Advanced Clinical Munich, DeutschlandAdvanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity wit ...
-
Health And Safety Advisor
vor 4 Wochen
BioTalent Munich, DeutschlandBioTalent has partnered up with a Consultancy that focus on delivering projects within the Pharmaceutical and Life Science industry who are on their search for a Senior Health and Safety Advisor based in Munich. · As a Senior Health and Safety Advisor, you'll play a pivotal role ...
-
BTA (m/f/d)
vor 2 Wochen
GULP – experts united Holzkirchen, Deutschland TEMP_JOBGet started as a biological-technical assistant with GULP now Our friendly colleagues in Holzkirchen also have the right position for you. We are currently looking for a BTA on behalf of our business partner in the pharmaceutical industry . Apply today and start your new job ...
-
Global Oncology HEOR
vor 3 Tagen
Daiichi Sankyo Europe Munich, DeutschlandPassion for Innovation. Compassion for Patients. · With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the wor ...
-
Director Health Economics
vor 3 Wochen
Regeneron Pharmaceuticals, Inc Munich, Deutschland GanztagsAs a Director Health Economics & Outcomes Research & Real World Evidence Oncology - Europe & Canada, you will play a pivotal role in shaping our cross-functional strategy and plans for generating and communicating HEOR evidence and tools. Your work will demonstrate the value prop ...
-
Office Manager
vor 2 Wochen
Manning Global AG Munich, DeutschlandOur client, a leading global ICT service provider, is recruiting for an Office Manager to join their business in Germany. · Position Title:Office Manager · Duration:6 months · Start Date:July 2024 · Location:Munich, Germany · Contact:Iulia Balan | · Job Description: · As the Off ...
-
Safety Physician
vor 3 Wochen
Daiichi Sankyo Europe Munich, DeutschlandPassion for Innovation. Compassion for Patients. · With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the wor ...
-
Regulatory Project Manager
vor 3 Wochen
Leaman Life Sciences Munich, DeutschlandRegulatory Affairs Project Manager · **Must have 8-10+ years Reg project management** · Company Overview · Boutique Regulatory Consulting services company · Based in Munich, Germany · Provide their clients a unique and tailor-made support service with European and US regulatory r ...
Submission Manager - Penzberg, Deutschland - Roche
Beschreibung
The 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 Technical Regulatory submissions. They have the knowledge and ability to work with all submission types across Health Authorities globally.
Primary duties and responsibilities:
Additional responsibilities:
Quality Related Job Accountabilities:
Qualifications:
Competencies and Skills:
Application period until at least: 21st Nov 2023 (application possible as long as the position is advertised)
Your application
You only need to upload your CV. Further documents will be requested if required.
Refer a Friend
This position is eligible for a bonus as part of our Refer a Friend program for Roche employees in Germany. In the event of a successful referral, a bonus will be paid in accordance with the applicable regulations and conditions.
Your
