Associate Director, CMC Regulatory Affairs

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan

Summary

CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with regulatory leadership, with a primary focus on U.S. Health Authority (FDA) interactions.

This role coordinates and oversees the preparation and review of CMC-related regulatory documents, supports Health Authority meetings and follow-up commitments, and partners closely with cross-functional teams in the U.S. (NS Pharma) and Japan (Nippon Shinyaku HQ) to ensure global alignment and timely issue resolution.

Responsibilities

• Plan and execute CMC regulatory activities including IND M3/IMPD-Quality for investigational products, and NDAs/BLAs and post-approval supplements/variations for marketed products.
• Lead and coordinate CMC-related FDA meetings (e.g., pre-IND; Type A, B, and C; and NDA/BLA-related meetings) in collaboration with Regulatory Affairs Strategy, including meeting strategy, material preparation, internal alignment, and submission logistics.
• Coordinate and oversee CMC dossier readiness and the preparation/review of CMC regulatory deliverables in eCTD format, including scientific/technical input for full regulatory compliance.
• Serve as the day-to-day CMC regulatory liaison for timely submission-ready of CMC-document through IND/CTA/NDA/BLA.
• Coordinate and support responses to CMC-related Health Authority information requests/questions in alignment with cross-functional stakeholders.
• Manage external CMC regulatory expert consultations (consultants/contractors) including selection support, deliverable expectations, quality review, and timeline/budget oversight.
• Partner with cross-functional teams (CMC, QA, Clinical, Nonclinical, Project Management, etc.) to align regulatory strategy and execution.
• Establish regulatory classification and filing strategy for CMC changes in manufacturing, analytical testing, and supply chain throughout the product life cycle.
• Ensure consistency and traceability of CMC regulatory positions across key documents (e.g., Module 2 QoS and Module 3 content).
• Maintain CMC regulatory documentation controls and inspection/audit readiness (e.g., version control, document traceability, decision logs, and submission trackers) to support timely, high-quality deliverables.
• Monitor and communicate evolving global regulatory requirements and guidance (e.g., ICH, FDA, EU), and proactively assess impacts and risks, and take required actions for programs.
• Support operational regulatory activities as needed, including coordination of cross-functional meetings, maintenance of submission trackers, and documentation of decisions and action items.
  
  

Experience (Required)

• Strong knowledge of U.S. FDA CMC regulatory requirements.
• Strong knowledge of ICH Quality guidelines
• Excellent English communication skills (written and verbal) suitable for Health Authority interactions and regulatory documentation.
• Working knowledge of CMC CTD/eCTD structure and the ability to ensure CMC content readiness and consistency.
• Experience working effectively in a cross-functional team environment.
  
  

Preferred Qualifications

• Strong knowledge of GMP
• Experience in rare disease
• Working understanding of EU regulatory requirements (EMA) and ability to support EU-related activities.
• Demonstrated ability to develop and execute CMC regulatory strategy throughout the product lifecycle.
• Excellent technical writing and editing skills for regulatory documentation and Health Authority correspondence (clear, consistent, defensible rationale).
• Strong organizational and project management skills, including prioritization, issue/risk tracking, attention to detail, and document control discipline (version control, traceability, decision documentation).
  
  

Education

• A bachelor’s degree in pharmacy, chemistry, or a related scientific discipline, or equivalent experience is required. MSc or PhD preferred.
• Typically, 8 – 10 years of experience in the CMC field of the pharmaceutical/biotechnology industry, including a minimum of 5 years of CMC regulatory affairs.
• A minimum of one NDA/BLA and multiple IND/CTA is also preferred.
  
  

Compensation And Benefits

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is $170,000 to $190,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Other Benefits Include

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
• Career Development, Progression and Training
• Flexible Work Arrangement Programs
  
  

Applications will be accepted until August 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.

NS Pharma is an EEO employer.