The Role

The Manager of Regulatory Operations plays a vital role in our Regulatory Affairs team. This role provides document editing, formatting and publishing support to facilitate accurate and timely preparation of Word and PDF documents associated with non-clinical studies, clinical studies, and CMC documentation in support of global regulatory submissions conforming to the electronic Common Technical Document (eCTD) format, and other submission standards as specified by FDA, ICH, and ROW guidelines.

In addition, the Manager of Regulatory Operations will assist in the implementation, maintenance, and support of systems and processes used within the Regulatory Affairs team. This position reports to the Head of Regulatory Affairs. This position will not have direct reports but must be able to operate effectively in collaboration internally with cross-functional team members and externally with vendors and partners.

Primary Responsibilities

• Coordinate and perform document editing, formatting, publication, and submittal of regulatory submissions as assigned by the Head of Regulatory Affairs.
• Compile and perform hyperlinking of electronic submissions using associated publishing tools.
• Ensure final document components are electronically archived according to departmental practices within RegDocs Connect Module (Regulatory EDMS) of the Montrium system.
• Assist with regulatory submission tracking and planning within the Regulatory Navigator of Montrium.
• Interface with Regulatory team members and appropriate functional staff regarding submission planning, document templates, and publishing.
• Review source documents for use related to eCTD compliance and provide formatting suggestions to create eCTD-ready documents as needed.
• Provide training, technical support, and coordination for Viracta team members, as necessary, throughout the process of creating eCTD-compliant PDF report compilations, including document troubleshooting and use of software and Accenture document templates.
• Organize and track all documents designated for major and minor submissions.
• Receive data, text, and proposed report templates from various sources and provide editing or reformatting, as needed to present information in a clear consistent style across documents.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Must Have/Required

• 5+ years of electronic publishing-related experience, or an equivalent combination of education and experience.
• Experience with publishing and submission of dossiers in eCTD and non-eCTD format.
• Advanced computer skills, specifically in Microsoft Office Word, formatting and style templates, Adobe Acrobat and Montrium.
• A superior multi-tasker, highly organized and successful in a fast paced, changing environment.
• Proven history of reading and interpreting documents such as operating and maintenance instructions, software manuals, study documents, and procedure manuals.
• Ability to follow complex direction/processes and solve complex problems under pressure.
• A proven, independent worker with a successful history of managing product lifecycle.
• A record of working effectively and cooperatively in a team environment under significant time pressure.
• Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
• Excellent oral, written, and interpersonal skills; with a reputation for cultivating collaborations across departments and the whole organization.

May Have/Preferred

• Experience in managing one or more direct reports.
• Advanced knowledge of electronic document management systems (EDMS) and Regulatory Information Management Systems (RIMS), including Montrium
• Experience with computer systems validation procedures, and the implementation and maintenance of Regulatory Information Systems and Processes
• Leadership in training and educating other Regulatory team members in submission publishing concepts
• Interfacing directly with technical contacts within FDA and other global health authorities

• Experience with rare diseases and hematology/oncology
• Experience in a small company and high growth, fast-paced environment