[Hiring] Manager, Regulatory Affairs (Operations) @AMER

Role Description

The Manager, Regulatory Affairs (Operations) 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 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.

• Collaborate with teams to guide the regulatory requirements and expectations for preparing compliant submission documents, including managing the document workflows for timely deliverables.
• 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 publishing systems (e.g., Lorenz docuBridge) and 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 to support and enhance 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.

Qualifications

• 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 required.
• 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 (e.g., Lorenz docuBridge), 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.

Requirements

• 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.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.