Job Description

Candidate will participate in global regulatory dossier preparation activities by coordinating cross-functional data gathering from teams of subject matter experts, from internal and external third parties. The primary function is to prepare drug substance, drug product and analytical sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, efficient processes for preparation of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy.

Responsibilities:

Author CMC submission documentation for all phases of clinical development, often under significant time pressure.

Author internal documentation of manufacturing control strategies to support CMC submission documentation.

Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrate strong negotiating, influencing, and leadership skills.

Manages completion of CMC regulatory submission documentation for multiple projects of moderate complexity utilizing a matrix management approach. Individually completes submission document authoring, and implements other creative approaches to conserve resources, and achieve efficiency with respect to time and budget.

Develop an organizational memory of regulatory issues. Review regulatory guidance documents to develop and maintain expertise. Coordinate authoring and reviews across CMC functions.

Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.