Director, Regulatory CMC Device and Combination Products

Overview

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.

• Lead the development of combination product regulatory strategy for assigned clinical-stage programs, identifying key issues, necessary remediation activities, and opportunities for acceleration throughout project/product life cycle
• Assess and communicate regulatory requirements to ensure all global development activities comply with applicable regulations and guidelines in each jurisdiction
• Facilitate the preparation for combination product-focused meetings with FDA, EMA, or national competent authorities, and participate in or lead the interactions with these agencies
• Serve as the device regulatory representative at internal CMC team meetings and device sub-team meetings
• Work within a cross-functional team to coordinate and prepare high quality, timely correspondence and regulatory submissions (e.g., original INDs, IND amendments, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development
• Provide regulatory input, review, and approval of core product development documentation (e.g., development plans, Instructions for Use, design verification and human factors protocols and reports, risk management reports, change impact assessments)
• Lead with appropriate team members and stakeholders to resolve outstanding combination product regulatory issues
• Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success
• Lead, coordinate and conduct regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations to Regulatory department, product development team, or executive management, as required
• Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities. Provide input on project-related budgets and ensure projects operate within capital and expense budget guidelines

• Requires a Bachelor’s degree in an engineering field such as mechanical, chemical, or biomedical engineering or science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required
• Minimum of 12 years of increasing responsibility in Regulatory Affairs within the biopharmaceutical or pharmaceutical industry
• Demonstrated recent successful Regulatory Affairs track record in the development, submission, and registration of new combination products (device with biologics, innovative medicines, drugs, 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 INDs, CTAs, NDAs/BLAs, or MAAs, and their maintenance
• Demonstrated experience interacting with the US FDA, EU, EMA, and other regulatory agencies
• Candidates must have proven strategic development capabilities related to device development (design controls), risk management (ISO 14971), new drug development, commercial support, partner management, as well as product lifecycle management activities
• Strong leadership abilities and the 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 10%
• The…