E2
jf_chemistry_manufacturing_controls_cmc::E2
SVP, Chemistry, Manufacturing & Controls

SVP, Chemistry, Manufacturing & Controls

manufacturingChemistry, 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 ()

$244,601$453,317

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2 of 8

Track

Executive

Family rungs priced

E1 · E2 · E3 · E4 · E5

11-0000

manufacturing

Coordinates

3 / 4 spaces

pay@2 · 2026-07

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

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