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Regulatory Document Specialist
vor 1 Monat
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 strong understanding of regulatory requirements and the ability to manage complex technical documents.
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, 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.
- Collaborate with internal partners, including Regulatory Publishing, Project Management, Business Systems, and others, to ensure seamless submission processes.
- 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 Roche-specific systems, processes, or other relevant tools.
- Support user acceptance testing for new or updated systems or electronic tools.
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.
Qualifications
- Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a 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 the 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, and 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.
