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: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. 
