Submission Manager

Job Summary

The 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 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 ensure 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 submission reviews and review adjudication meetings, performing live editing to capture stakeholders' decisions.
• Collaborate with internal partners, including Regulatory Publishing, Project Management, Business Systems, and others.

Additional Responsibilities

• Facilitate knowledge sharing and best practice workshops, contributing to continuous improvement.
• Lead or participate in teams for special or ongoing initiatives and projects.
• Participate in the development and implementation of new or updated PTR and/or specific systems, processes, or 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.