Associate Director, CMC Regulatory Affairs

NS Pharma Inc•Paramus, NJ

5h•$170,000 - $190,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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).

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.