Associate Director, Regulatory Affairs Operations

Viridian Therapeutics, Inc.; United States; Hybrid; USD 163,000 - 200,000; Full time

Benefits offered by this job

Competitive pay and stock options

Comprehensive medical, dental, and vision plans

Generous vacation plan

Job summary

A biotech company is seeking an Associate Director of Regulatory Affairs Operations to manage regulatory submissions and ensure compliance with industry standards. The candidate must have at least 10 years of experience in Regulatory Operations, specifically within a Biotech or pharmaceutical setting. Expertise in tools like Veeva RIMs is essential. This role offers flexibility with the option to work remotely or from the company's Waltham, MA headquarters. Competitive benefits and a commitment to ethical standards are part of the offering.

Qualifications

• 10+ years of experience managing Regulatory Operations in a Biotech or pharmaceutical company.
• Strong project management skills in Regulatory Affairs.
• Proven strategic development capabilities related to new drug development.

Responsibilities

• Manage the end-to-end publishing of regulatory submissions.
• Coordinate with external vendors for submission-related activities.
• Proactively provide submission status updates to stakeholders.

Skills

Veeva RIMs

Regulatory Operations

Project Management

Leadership

Communication

Education

Bachelor’s degree

Tools

Microsoft Office Suite

Job description

Associate Director, Regulatory Affairs Operations

Join to apply for the Associate Director, Regulatory Affairs Operations role at Viridian Therapeutics, Inc.

Base pay range

$163,000.00/yr - $200,000.00/yr

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 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)

• Manage the end-to-end publishing (preparation through delivery) of regulatory submissions (e.g., INDs, BLAs, and MAAs) in electronic format according to global health authority requirements
• Serve as the point of contact for document formatting, PDF specifications and eCTD authoring templates. Manage document workflows in Veeva RIMs as needed and gather submissions from functional areas
• Support key functions within the Regulatory Operations team and across the organization. This includes overseeing submission projects, including tracking, assembly, submission, and archiving regulatory documents in collaboration with other team members and vendors
• Maintain knowledge of regulatory guidelines and industry standards related to electronic submissions (eCTD) and publishing tools
• Ensure efficient regulatory submission process, maintaining high standards of quality
• Ensure electronic assembly of all submissions is planned, coordinated, and delivered on time, and adhere to regulatory standards in collaboration with external vendors
• Coordinate with external vendors and consultants as needed for submission-related activities.
• Strong working knowledge of Veeva RIMs, publishing software and eCTD regulations. Maintain submissions in Veeva RIM system and ensure that content plans and regulatory records are up to date
• Ensure templates and style guides are being utilized for regulatory submissions.
• Work closely with other members of the Regulatory Affairs team and provide support to projects as needed
• Collaborate with Regulatory Affairs program leads to track and monitor key submission activities
• Ensure roles and responsibilities regarding submissions from project team members are clearly documented
• Proactively provide submission status updates to designated stakeholders via dashboards and milestone reports
• Ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions
• Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation
• May assist in the management of special projects as needed, e.g., oversight of system/process improvement projects
• Other Regulatory Affairs duties as assigned or as business needs require

Qualifications

• Requires a Bachelor’s degree with 10+ years of experience managing Regulatory Operations in a Biotech or pharmaceutical company
• Expert working knowledge of Veeva RIMs, publishing software and eCTD regulations
• Knowledge of INDs, BLA, MAA and document lifecycle activities
• General knowledge of drug development
• Candidates must have proven strategic development capabilities related to new drug development, commercial support, partner management, as well as product lifecycle management activities
• Strong leadership abilities, including experience leading multi-disciplinary project teams, and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner
• Strong oral and written communication, time management, and team-oriented leadership skills are essential
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
• Strong project management skills in Regulatory Affairs
• Proven mindset of proactive continuous improvement
• Strong attention to detail
• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint)
• Preferred: Project/program management training
• Ability to travel up to 5%
• The salary range for this position is commensurate with experience

Benefits

• 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.