Associate Director, Regulatory Affairs

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.

Responsibilities (including, but not limited to):

• Represent Regulatory Affairs on cross-functional program teams for assigned programs
• Lead day-to-day regulatory activities, maintain accurate regulatory documentation and timelines and contribute to development and execution of global regulatory strategies
• Prepare and review regulatory submissions including INDs, CTAs, amendments, and briefing documents, and marketing applications.
• Support meeting preparation with health authorities, including FDA, to facilitate assessment of IND applications
• Coordinate responses to Health Authority queries
• Proactively monitor for and anticipate risks; develop effective mitigation strategies to identified risks; assess likelihood of technical success for proposed 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, providing guidance to the team to ensure developmental plans align with regulatory expectations.
• Monitor changes in regulatory requirements and medical innovation in the relevant therapeutic areas; assess their potential impact and provide guidance to educate and inform project team(s) and leadership decisions
• 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
• Participate in or lead departmental and cross-functional task forces and initiatives
• Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions
• Other Regulatory Affairs duties as assigned or as business needs require

Qualifications:

• Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required
• Minimum of 10 years of increasing responsibility in Regulatory Affairs within the biopharmaceutical industry, or 5 years of experience plus an advanced degree (e.g., PhD, PharmD, JD)
• Demonstrated experience in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and/or international countries
• Proven experience in the review, authoring, and/or managing of components of regulatory submissions such as of INDs, CTAs, NDAs/BLAs or MAAs, and their maintenance
• Experience contributing to strategic development related to new drug development, commercial support, partner management, as well as product lifecycle management activities
• Strong communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
• 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
• Proven mindset of proactive continuous improvement
• Strong attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 25%
• The 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 coverage
• 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.