Submission Manager

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 :

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

Additional responsibilities :

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

Quality Related Job Accountabilities :

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

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 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

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

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.

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