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Regulatory Submission Specialist

vor 3 Monaten


Penzberg, Bayern, Deutschland Roche Vollzeit

Position Overview

The Regulatory Submission Specialist is responsible for ensuring the delivery of high-quality regulatory submissions to health authorities across the globe. This role involves editing intricate technical documents and managing various regulatory submission projects based on business requirements. The specialist applies their expertise in submission management to contribute effectively to the daily operations of Pharma Technical Regulatory submissions, possessing the knowledge to handle all submission types across global health authorities.

Key Responsibilities:

  • Edit complex technical documents to enhance clarity, grammar, spelling, and punctuation, ensuring compliance with applicable regulatory guidelines and Roche standards.
  • Oversee the flow of information and data entry into the regulatory information management system, maintaining data accuracy and quality.
  • Provide coordination, compilation, and submission management support for 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 in 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 content delivery and provide status updates.
  • Coordinate and deliver 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 across various departments.
  • Provide input on future system enhancements and updates to business processes and submission model documents.

Additional Duties:

  • Promote knowledge sharing and best practice workshops to foster continuous improvement.
  • Lead or actively participate in teams for special 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 needed.

Quality Assurance Responsibilities:

  • Stay informed about internal and external developments, trends, and dynamics relevant to Pharma Technical Regulatory operations.
  • 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.
  • Demonstrate a mindset focused on continuous improvement, identifying opportunities to streamline processes.

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 editing background with at least three years of professional experience in a scientific or technical field is preferred.
  • Previous experience with regulatory documents in CTD structure and familiarity with ICH, FDA, and EMA guidelines is beneficial.
  • Expert-level proficiency in Word, Excel, PowerPoint, and Adobe Acrobat, along with experience in document management and sharing systems.
  • Excellent teamwork skills with the ability to interface effectively with a diverse range of stakeholders.
  • Strong organizational and time management skills, capable of delivering under pressure and adapting to changing priorities.

Competencies and Skills:

  • Strong written and verbal communication abilities.
  • Capable of listening well and articulating ideas clearly while being open to feedback.
  • Understands the perspectives of various functional areas within the organization.
  • Analyzes information logically and makes timely decisions.
  • Effectively manages change and addresses concerns with patience.
  • Demonstrates project management skills by consistently achieving multiple tasks on time.
  • Proactively addresses issues as they arise.
  • Recognizes and appreciates the contributions of peers.
  • Encourages idea exchange and support among colleagues.
  • Helps others align their work with the mission of Pharma Technical Regulatory.
  • Clearly articulates long-term objectives and strategies.

Application Process

Candidates are required to upload their CV. Additional documents may be requested if necessary.

Referral Program

This position is eligible for a bonus through the Refer a Friend program for Roche employees. A bonus will be awarded in accordance with applicable regulations upon a successful referral.