Viridian Therapeutics - Waltham, MA
posted 3 days ago
About the position
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 plan, prioritize, and conduct activities in close collaboration with Regulatory and cross functional leads to ensure timely and compliant submissions. This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities
- Support key functions within the Regulatory Operations team and across the organization.
- Oversee submission projects, including tracking, assembly, submission, and archiving regulatory documents in collaboration with other team members and vendors.
- Ensure efficient regulatory submission process, maintaining high standards of quality.
- Ensure electronic assembly of all submissions are planned, coordinated, and delivered on time, and adhere to regulatory standards in collaboration with external vendors.
- Directly interface with Viridian's publishing and submissions vendor regarding regulatory sequences to the INDs and BLAs currently in effect.
- Maintain submissions in Veeva Vault RIM system and ensure that content plans and regulatory records are up to date.
- Ensure that all US/ex-US submissions and correspondence files are up to date.
- Ensure templates and style guides are being utilized for regulatory submissions.
- Work closely with other members of the Regulatory team and providing support to their projects as needed.
- Collaborate with Regulatory 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.
- 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.
Requirements
- Requires a Bachelor's degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences with 7+ years of experience managing Regulatory Operations in a Biotech or pharmaceutical company.
- General knowledge of drug development.
- 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.
- 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, etc.).
- Strong working knowledge of Veeva RIMs, publishing software and eCTD regulations.
Nice-to-haves
- Project/program management training.
Benefits
- Competitive pay and stock options for all employees.
- Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents.
- 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.
