Senior Director, Regulatory Affairs

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 Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs will be responsible for providing company-wide regulatory direction for product development and guidance to develop rapid, successful strategies for market approval(s) aligned with business objective(s) and compliance with applicable US, EU and international regulations. The Senior Director, Regulatory Affairs 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. The Senior Director, Regulatory Affairs 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 role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.

Responsibilities (including, but not limited to):

• Develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans
• Participate in or lead departmental and cross-functional task forces and initiatives
• Demonstrate ability to anticipate risks and be responsible for developing solutions to identified risks; understand probabilities of technical success for the solutions
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
• Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide the team in established and building appropriate regulatory strategy
• Demonstrate a solid understanding of current US and EU regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas
• Demonstrate increasing independence in the area of regulatory strategy, such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies
• Provide strategic and tactical advice to internal teams to achieve timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements
• Closely collaborates with external partners and stakeholders to ensure alignment with the partner and seamless execution of endorsed regulatory strategies
• Direct the preparation of INDs, CTAs, amendments, briefing documents, and marketing applications
• Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates responses to Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues
• Represent company at regulatory agencies for assigned products, including planning and conducting meetings as well as ensuring submitted documents are compliant and of the highest quality
• Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Medical Writing, Reg CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions
• Regularly report to management on progress against objectives and plans. Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team
• Other Regulatory Affairs duties as assigned or as business needs require

Requirements

• Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required.
• Minimum of 15 years of increasing responsibility in Regulatory Affairs within the biopharmaceuti