Director, Cmc Dossier Management

Job Description
Leads global regulatory dossier preparation activities by coordinating cross-functional teams of subject matter experts, from internal and external third parties. The primary function is to ensure consistent preparation of 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, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provide drug development experience and advice to the CMC team. Influence development of new regulatory guidance, assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex projects, anticipate regulatory questions, and help drive first pass approvals
Responsibilities
Author and coordinate submission documentation for all phases of clinical development, with emphasis on later phase programs and marketing applications, often under significant time pressure. Drive team resolution and author responses to questions from regulatory authorities.
Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of global regulatory submission documents. Maintain awareness of global regulatory requirements on pharmaceutical development. Ensure necessary changes to regulations are implemented in local practices and procedures.
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.
Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission documentation. Develop and maintain submission document templates for CMC regulatory documents in collaboration with CMC Regulatory and Process R&
D.
Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop mitigation strategies. Provide local expertise in the use of e-Docs.
Develop an organizational memory of regulatory issues. Review regulatory guidance documents to develop and maintain expertise. Coordinate document authoring and reviews with various groups outside of DPD such as Process R&
D Operations S&
T, preclinical safety, PK, and QA.
Interface with CMC Regulatory personnel to ensure consistency across projects. Represent the CMC team in communication of issues to DPD management.
Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.
Provide feedback to functional area management on performance of contributors. Capable of overseeing non-exempt personnel.