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.

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Associate Director, CMC Regulatory Affairs