Manager, Regulatory Affairs (Operations)

See Yourself at Telix

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 Manager, Regulatory Affairs (Operations) position is responsible for providing expertise regarding the preparation of regulatory submission documents and dossiers, as well as coordinating and executing 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.

Key Accountabilities:

• 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 submissins, overseeing internal RA SOW/PO system administration, and generating metric reports for leadership.

Position Requirements

Education and Experience:

Key Capabilities:

• 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