ABOUT THE ROLE:

Chroma Medicine is seeking a VP/SVP, Regulatory Affairs and Quality Assurance to be a pivotal leader responsible for developing and executing comprehensive global regulatory strategies for our rapidly advancing novel epigenetic editing medicines portfolio. Reporting directly to the Chief Executive Officer, this leadership role will play a critical part in shaping the regulatory pathway and ensuring compliance with global regulatory requirements. The incumbent will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registration strategies for all Chroma products, including initial regulatory efforts on preclinical pipeline programs. The role is also accountable for furthering the development and providing oversight of the Chroma quality systems and compliance strategies. This position offers a unique opportunity to make a significant impact while fostering a culture of continuous improvement and integrity within Chroma. The candidate will work in in a fast-paced environment, develop short-term and long-term regulatory strategies and be responsible for timelines and budget planning. They will liaison with external consultants and agencies and require a deep understanding of gene therapy products.

RESPONSIBILITIES:

• Regulatory Strategy Development and Execution: Craft and execute robust regulatory strategies aligned with business objectives for the development and commercialization of Chroma’s products. Lead all regulatory activities for all assets to ensure alignment and compliance with local and regional GxP requirements and registration requirements as well as with company policies. Accountable for development and implementation of effective CMC regulatory strategies across products and product life cycles
• Regulatory Operations: Builds, leads and manages Regulator Operations, ensuring robust systems and processes, working with vendors as needed, to assure compliant, scientifically valid submissions, globally. Oversee the preparation, review, and submission of regulatory documents (INDs, BLAs, CTAs, etc.), including Reg CMC, to health authorities (FDA, EMA, etc.) ensuring compliance, adherence to timelines and maintenance of electronic/paper files to support all documentation systems.
• Quality: Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements of relevant authorities. Interprets regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute strategy to support overall product quality. Collaboratively develops and implements standards, policies, and procedures for GMP, GLP and GCP compliance. Partners with relevant functions to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation of regulatory requirements and expectations. Oversees and manages vendors supporting quality and compliance.
• Collaboration and Communication: Act as a liaison with regulatory agencies, fostering productive relationships, and representing the company in regulatory interactions. Communicate regulatory updates and requirements internally to cross-functional teams.
• Compliance and Risk Management: Monitor regulatory landscape changes, assess potential risks, and proactively develop mitigation plans. Ensure adherence to regulations, guidelines, and standards. Ensure leadership and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Regulatory Expertise: Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements. Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Leadership and Team Management: Build, lead, and mentor a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous learning. Manage regulatory consultants, CROs, and other vendors, as necessary. Manage budget within financial goals; review and approve invoices against approved budget. Align functional growth with corporate goals.
• Cross-functional Collaboration: Collaborate closely with R&D, Clinical Development, CMC, and other relevant departments to ensure regulatory alignment across all stages of product development.

SKILLS & COMPETENCIES:

• Strong negotiation and influencing skills, coupled with strategic thinking and a solution-oriented mindset
• Clear and adaptive communication, exceptional leadership, and a collaborative approach, fostering a constructive and team-based culture
• Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Strong oral and written communication skills with experience presenting both internally across all levels of the organization and externally to other interested parties
• Ability to thrive in a fast-paced, innovative, and, at times, uncertain or changing environment while remaining flexible, proactive, and resourceful
• Adept at prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues, and balancing competing priorities effectively
• Collaborative and team-oriented mindset with a desire to positively impact a new company’s evolving culture
• Passionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge science

QUALIFICATIONS:

• Advanced degree in life sciences or a related field (PhD, MD, or equivalent) preferred.
• Extensive experience (10 years) in regulatory affairs within the biopharmaceutical industry, with experience in genomic medicine
• Experience in building and executing clinical and CMC regulatory strategy in the context of genomic medicine
• Proven track record of successful regulatory submissions and interactions with health authorities, preferably including experience with pre-IPO companies and innovative therapies.
• Deep knowledge of global regulatory requirements, guidelines, and best practices.
• Experience in interfacing with regulatory authorities and leading regulatory submissions , briefing documents, and other regulatory documents.
• Proven track record in successful global registrations a plus
• Knowledge of the Code of Federal Regulations and FDA, EMA, and ICH guidelines
• Experience and knowledge in the preparation of electronic submissions (CTD)