SVP, Chemistry, Manufacturing & Controls
manufacturing › Chemistry, Manufacturing & Controls (CMC) · E2 — E2 — Senior Director (Executive) · Executive
Executive who leads the overall CMC strategy, manufacturing science, and regulatory compliance function across a pharmaceutical or biotech company's product portfolio.
Median pay · United States · annual
$332,990 USD
▲ +90.4% vs E1 on this ladder
Typical range ()
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What this role is
Executive who leads the overall CMC strategy, manufacturing science, and regulatory compliance function across a pharmaceutical or biotech company's product portfolio. At the Senior Director (Executive) (E2) level, the role owns multiple functions or a major area, multi-function strategy and risk, and drives major-area outcomes. Leads function leaders.
What this level does
- Leads multiple CMC-related functions (regulatory CMC, analytical development, manufacturing science, quality) through VPs and Directors, integrating them into a coherent development-to-commercial pathway
- Shapes cross-functional CMC strategy where decisions on manufacturing scale-up, method validation and submission timing carry consequences material to program viability
- Negotiates critical CMC matters directly with health-authority reviewers and top partner leadership, resolving abstract technical and regulatory issues of high consequence for the pipeline
- Governs vendor and external-manufacturing partner networks at portfolio scale, setting the standards for method transfer, remediation and compliance across all managed programs
- Establishes the risk framework that principal scientists and directors apply when assessing regulatory success and mitigation across late-stage and commercial products
- Knowledge applied
- Applies cross-functional CMC expertise spanning regulatory, analytical, manufacturing science and quality to integrate multiple functions into one development-to-commercial pathway.
- Complexity & problem solving
- Tackles abstract, high-consequence issues where scale-up, validation and submission-timing decisions may affect program viability.
- Collaboration & interaction
- Negotiates critical CMC matters with health-authority reviewers and top partner leadership.
- Typical experience
- 15+ years, with strategic leadership of multiple CMC functions or a significant development unit.
Skills at this level
- CMC Regulatory Submission Management
- — Manages execution of CMC documentation including IND, IMPD, CTA, NDA, BLA, post-approval supplements, annual reports and registration renewals, and authors responses to health-authority questions.
- Phase-Appropriate CMC Strategy
- — Develops and executes global product and project regulatory strategies with robust assessment of global CMC requirements matched to the product's stage of development.
- Regulatory Success Risk Assessment
- — Assesses the probability of regulatory success for a product and defines the risk-mitigation measures needed to secure regulatory milestones through development.
- Analytical Method Life Cycle Management
- — Owns method remediation, validation, transfer, troubleshooting and OOT/OOS investigations along with data trending analysis for late-stage and commercial methods.
- Technology Transfer & Manufacturing Readiness
- — Directs transfer of processes and methods into manufacturing and ensures CMC documentation and processes are ready to support production at scale.
- External Manufacturing Partner Management
- — Selects and governs contract manufacturers and vendors, managing them to deliver CMC deliverables and maintain product integrity across the drug-development process.
- Health Authority Negotiation
- — Represents the organization's CMC positions to regulatory agencies, negotiating critical technical and compliance matters and defending the chemistry and manufacturing story.
- Global CMC Compliance & Audit Oversight
- — Sets and maintains large-scale manufacturing compliance posture and directs compliance audits so that CMC practices meet evolving regulator expectations across regions.
- CMC Product Leadership
- — Serves as accountable lead for a product's entire CMC regulatory destiny, coordinating delivery of all regulatory milestones through development and into commercialization.
- Cross-Functional CMC Integration
- — Aligns regulatory affairs, quality assurance, analytical development and manufacturing to ensure product integrity and coherent CMC deliverables throughout drug development.
- Technical Authority & Mentorship
- — Acts as scientific and technical authority within and across CMC functions, guiding local, regional and global associates so development and regulatory strategies stay current.
- Corporate CMC Policy Development
- — Drives company-wide CMC policies and regulatory-negotiation standards that define how subordinate development, analytical and manufacturing functions operate.
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As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
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