Associate Director, Regulatory Affairs

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Viridian Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs in Waltham, MA. The role involves leading day-to-day regulatory activities for our TED and TSHR portfolio and working with cross-functional teams to align with corporate strategy.

You will develop regulatory strategies, anticipate obstacles, and advance organizational policies to support product development and approvals in the intended markets. Office-based role with three days per week in the office.

Qualifications

• Regulatory Affairs expertise across product development and approval processes.
• Experience collaborating with cross-functional teams to anticipate regulatory obstacles.

Responsibilities

• Lead day-to-day regulatory activities for TED/TSHR programs and other portfolio initiatives.
• Represent Regulatory Affairs on cross-functional teams and align with corporate strategy.
• Develop and advance regulatory policies and procedures to support product development and approvals.

Job 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 Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian’s Thyroid Eye Disease (TED) and TSHR portfolio. This individual will work with the cross-functional team to combine knowledge of scientific, clinical, regulatory, and business to lead and support the development of products that meet the regulatory requirements in the intended markets. This individual will develop and advance organizational policies and procedures, while also anticipating regulatory obstacles and risks/emerging issues that may impact current or future projects while developing the corresponding solutions.

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.