Regulatory Submission Coordinator

vor 1 Monat

Penzberg, Bayern, Deutschland Roche Vollzeit

Position Overview

The Regulatory Submission Coordinator 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 coordinator applies their expertise in submission management to support the daily operations of Pharma Technical Regulatory submissions, demonstrating the ability to work with all submission types internationally.

Key Responsibilities:

  • Edit complex technical documents for clarity, grammar, spelling, and punctuation, ensuring compliance with relevant regulatory guidelines and Roche standards.
  • Oversee the information flow and data entry into the regulatory information management system, maintaining accuracy and quality of data.
  • Provide coordination and management support in 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 on regulatory submissions and compliance matters.
  • Facilitate communication and collaboration to meet submission deadlines and plan for future requirements.
  • Manage document flow through document-sharing systems and ensure version control throughout the submission process.
  • Liaise with technical subject-matter experts to ensure timely delivery of content and provide status updates.
  • Coordinate 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, including Regulatory Publishing and Project Management.
  • Provide input on enhancements to systems, 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 or ongoing 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 relevant to Pharma Technical Regulatory operations.
  • Contribute to the development and maintenance of policies and Standard Operating Procedures.
  • Ensure compliance with Roche standards and ICH guidelines for eCTD submissions.
  • Adhere to regulations and company policies, complying with all Roche Standard Operating Procedures.
  • Demonstrate a mindset focused on continuous improvement by identifying opportunities to enhance 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 background in editing, with at least three years of professional experience in a scientific or technical field 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 systems.
  • Excellent teamwork skills and the ability to effectively interface with a diverse range of stakeholders.
  • Strong organizational and time management skills, with the ability to deliver under pressure.

Competencies and Skills:

  • Strong written and verbal communication abilities.
  • Active listening skills and the ability to articulate ideas clearly.
  • Understanding of different functional perspectives within the organization.
  • Analytical thinking and problem-solving capabilities.
  • Effective change management skills.
  • Proven project management skills, consistently achieving goals on time.
  • Proactive issue management.
  • Recognition of team contributions and fostering a supportive environment.
  • Ability to align team efforts with organizational objectives.
  • Skill in articulating long-term strategies and promoting a vision.

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