Associate Director/Director, Regulatory Affairs-CMC
$180k - $235k USD
nChroma Bio is a clinical-stage genetic medicines company developing engineered epigenetic silencers to overcome the limitations of existing therapies and enable next-generation genomic medicines. By combining in vivo delivery and gene-regulating technologies, nChroma is designing optimal solutions to deliver precise, potent and durable treatments for patients with high unmet needs. nChroma’s lead candidate, CRMA-1001, is a clinical-stage, liver-directed epigenetic silencer in development as a potential functional cure for chronic hepatitis B. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, nChroma is redefining targeted in vivo genetic medicine with the initial goal of treating diseases affecting the liver, blood, cardiovascular and central nervous systems.
We’re building a culture and organization to support this important mission, bringing together individuals that thrive in a supportive environment where diverse perspectives and a passion for discovery drive cutting-edge science and breakthrough medicines.
ABOUT THE ROLE
The Associate Director/Director, RA-CMC oversees the management, coordination and execution of regulatory CMC activities for nChroma’s early development programs. This position supports nChroma’s clinical registration and manufacturing efforts and partners with the manufacturing team, clinical operations and quality functions, and other regulatory team members. This role reports into the VP Regulatory Affairs.
RESPONSIBILITIES
- Lead cross-functional teams responsible for global RA-CMC submissions (IND/IMPD/CTAs) and responses to Health Authority questions.
- Provide strategic regulatory input to the Tech Ops and Quality organizations pertaining to global product development requirements
- Define and implement global RA-CMC regulatory strategy to support development and commercial objectives.
- Communicate RA-CMC strategies, risks, and plans effectively to leadership and project teams.
- Ensure regulatory strategies align with business goals and meet Health Authority requirements.
- Monitor and influence global RA-CMC environment changes; contribute to internal process and policy improvements.
SKILLS & COMPETENCIES:
- Experience in gene therapy and/or RNA therapeutics strongly preferred
- In-depth knowledge of global regulations, ICH/GMP requirements, CTD format, and CMC change management systems.
- Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
- Ability to work independently in a fast-paced environment
- Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
- Excellent communication skills, regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail
QUALIFICATIONS:
- B.A. and/or M.S. with at least seven years of relevant experience within the biotech or pharmaceutical industry. Minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.
The salary range for this role is $180k - $235k
nChroma Bio is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, nChroma Bio complies with applicable state and local laws governing nondiscrimination in employment.