Global Regulatory Affairs Operations Submission Manager

See Yourself at Telix

The Global Regulatory Affairs (GRA) Operations - Submission Manager is responsible for the management, organization, and delivery of regulatory submission and submission ready documents at Telix, ensuring efficient and compliant document workflows between its departments. The Submission Manager position is responsible for providing expertise regarding the preparation of regulatory submission documents and dossiers, as well as coordinating and execute document workflows including document formatting and the finalization of documents through to submission readiness with excellent attention to detail. The position will utilize regulatory operations tools to ensure the highest quality document standards are met across departments, the company, and within agency specifications and expectations.  The ideal candidate will facilitate workstreams and document preparation tasks within tight deadlines. They will have a strong understanding of industry standards, coupled with the strategic thinking needed to guide our organization towards optimal document submission readiness activities. Therefore, the ideal candidate should have a strong understanding of regulatory submission management tools and eCTD templates such as those in the Acumen Templates suite and toolbar. They will have expert level knowledge of Veeva RIM, Veeva Collaborative Authoring, CSC toolbox, and MS WORD to effectively perform key document preparation and management responsibilities e.g. formatting and pre-submission preparation. They should also be able to manage updates to the Telix Style Guides and train relevant staff in alignment with Telix’s document readiness processes as well as troubleshoot related issues, as needed.

Key Accountabilities

• Collaborate with teams to guide the regulatory requirements and expectations for preparing compliant submission documents, including managing the document workflows for timely deliverable
• Align and work within submission plans, effectively managing submission document preparation deadlines across product portfolio, coordinating activities between relevant functions
• Stay current on industry trends relevant to global electronic submissions as it relates to document preparation for eCTD submission.
• Participate, as needed for the maintenance activities of the Regulatory Information Management Systems (RIMS) and EDMS (e.g. Veeva Submission and Archive Vaults).
• Understand the eCTD publish-readiness requirements as defined by the industry and company.
• Develop and manage the document preparation process through the utilization of templates and internal style guides to ensure both QC and formatting standardizations.
• Collaborate and in most case lead the regulatory operations document infrastructure through the continuous refinement of appropriate procedures, standards, templates, and style guides related to authoring, formatting, reviewing, and publishing of submission documents.
• Provide guidance on document-related best practices and regulatory requirements to internal teams and troubleshoot and/or train as needed.
• Be committed to process improvement for efficiencies across business practices as it relates to preparing Telix’s documents for Regulatory submission both establishing (where needed) and upholding excellent quality standards.
• Assist Regulatory Operations management with administrative and compliance tasks, including facilitating Health Authority portal submissions, overseeing internal RA SOW/PO system administration, and generating metric reports for leadership.

Education and Experience:

• Bachelor's degree or equivalent experience is required
• 7+ years of experience in Regulatory Affairs Operations required. Preferred experience with US/Canada and/or European regulatory legislation and procedures.
• Demonstrated experience in preparing documents for submission: Formatting, QCing, submission-ready preparation and finalization of regulatory document for eCTD submission (e.g., New Drug Applications (NDA) and/or EU Marketing Authorization Applications).
• Strong organizational skills with an ability to manage multiple projects and deadlines.
• Excellent attention to detail and accuracy in documentation.
• Expert knowledge of CTD/eCTD structure, format, and submission requirements.
• Experience with MS Word (e.g., Authoring Templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g. CSC Toolbox and Veeva Collaborative Authoring or equivalent).
• Strong project management skills; a keen attention to detail; and to assess and advise teams on potential impact or changes in project timelines.
• Outstanding written and verbal communication skills, including the ability to communicate effectively with internal colleagues at various levels, and with external vendor partners.
• Self-motivated and results-oriented with an enthusiastic attitude and the ability to work independently in a remote setting in multiple time zones where needed as well as build relationships and work effectively in a team environment.
• General understanding of dossier Life Cycle Management is desired.
• Aptitude for enjoying working with colleagues from different functions and locations and cultures; reaching out proactively, seeking the answer, engaging the team where needed.
• Fluent in English (speaking, reading, and writing), any additional European language is an asset.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges