Job Description
Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-functional teams of subject matter experts, from internal and external third parties. The primary function is to ensure consistent preparation of CMC 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 provides drug development experience and advice to the CMC team. Influences 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 of biologics, 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 biologics 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.
- Serve as the primary Dossier Strategy & Leadership (DSL) representative to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of 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.
- 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 DSL management.
- Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.
- Actively facilitate the establishment of high performing teams. May mentor/supervise a team of one or more dossier authors and guide and evaluate the performance of those individuals.