Description
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Senior Director, Regulatory Operations, the Associate Director, Regulatory Affairs Operations will be responsible for the execution of Regulatory Submissions operational activities in support of pipeline programs. This role will include successfully planning, prioritizing, and conducting activities in close collaboration with Regulatory Affairs team members and cross-functional leads to ensure timely and compliant submissions.
May be fully remote or based in Waltham headquarters. Our office-based employees are required to work in the office three (3) days a week. Travel to headquarters may be required at discretion of management.
Responsibilities (including, but not limited to):
- Lead the end-to-end publishing of global regulatory submissions within IQVIA RIM Smart, ensuring accuracy, compliance, and on-time delivery to global Health Authorities
- Serve as a subject matter expert (SME) for RIM Smart publishing, supporting internal users, troubleshooting technical issues, and contributing to process improvements
- Create and maintain submission records, metadata, and content plans in RIM Smart, ensuring alignment with submission strategy, application details, and regional requirements
- Contribute to the transition from outsourced to in-house publishing, including knowledge transfer, training support, and continuous process optimization
- Maintain submissions in Veeva RIM, ensuring content plans and regulatory records are accurate and up to date
- Manage document workflows in Veeva RIMs as needed and coordinate the collection of submission documents from functional areas
- Serve as the primary point of contact for document formatting, PDF specifications, and eCTD authoring templates
- Coordinate submission readiness activities, including lifecycle management and final publishing outputs; support Health Authority transmission activities, including document assembly confirmation and archiving of submission outputs, validation reports, and acknowledgements in inspection-ready repositories
- Apply eCTD standards and regional technical requirements, including dossier structure, granularity, leaf titles, hyperlinks, bookmarks, and lifecycle operations
- Perform or coordinate submission-level quality control (QC) and technical validation to confirm compliance prior to Health Authority transmission
- Collaborate cross-functionally with Regulatory Affairs, Medical Writing, CMC, and external partners to resolve publishing issues and ensure submission completeness
- Maintain submission documentation, audit trails, and records in accordance with internal SOPs, work instructions, and regulatory expectations
- Maintain current knowledge of regulatory guidelines and industry standards related to electronic submissions (eCTD) and publishing tools
- Coordinate with external vendors and consultants as needed for submission-related activities
- Ensure approved templates and style guides are consistently utilized for regulatory submissions
- Work closely with members of the Regulatory Affairs team, providing support to projects as needed
- Proactively provide submission status updates to designated stakeholders through dashboards and milestone reporting
- Ensure regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions
- Identify and recommend solutions for timeline risks, issues, or obstacles, engaging appropriate leads for mitigation and resolution and ensuring issues reach a clear conclusion or recommendation
- Assist with special projects as needed, including oversight of system and process improvement initiatives
- Perform other Regulatory Affairs duties as assigned or as business needs require
Requirements
- Bachelor’s degree required, with 10+ years of experience managing Regulatory Operations in a biotech or pharmaceutical company
- Experience publishing regulatory submissions using IQVIA RIM Smart publishing systems
- Experience supporting routine submissions, INDs, BLAs, and MAAs
- Strong understanding of eCTD structure, lifecycle management, and Health Authority technical requirements
- Experience supporting in-house regulatory publishing models and system-based submission workflows
- Expert working knowledge of Veeva RIMs, publishing software, and eCTD regulations.
- General knowledge of drug development
- Demonstrated strategic development capabilities related to new drug development, commercial support, partner management, and product lifecycle management activities
- Strong leadership skills, including experience leading cross-functional project teams and influencing decision-making in a diplomatic and collaborative manner
- Excellent oral and written communication, time management, and team-oriented leadership skills
- Ability to work independently, within multi-disciplinary teams, and with external partners and vendors.
- Strong project management skills within Regulatory Affairs
- Proven mindset of proactive continuous improvement
- Strong attention to detail and organizational skills
- Ability to thrive in a dynamic, fast-paced environment while fostering strong internal and external collaboration
- Strong commitment to ethical standards
- Proficiency with Microsoft Office (Word, PowerPoint, Excel, Outlook, SharePoint)
- Preferred: Project or program management training
- Ability to travel up to 5%
- Salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
· Competitive pay and stock options for all employees
· Competitive medical, dental, and vision plans
· Fertility and mental health programs
· Short- and long-term disability coverage
· Life, Travel and AD&D
· 401(k) Company Match with immediate company vest
· Employee Stock Purchase plan
· Generous vacation plan and paid company holiday shutdowns
· Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.