Leads global regulatory dossier preparation activities for novel synthetic molecules 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.
Responsibilities:
- Author and coordinate submission documentation for all phases of clinical development of synthetic molecules, 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.
- 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.
- Embedded in the CMC team throughout development to collaborate on control strategy development and the planning of the data packages that will support the strategies.
- Participates in benchmarking activities to gather insights in industry trends and identify & implement opportunities ensuring control strategies are up-to-date.
- Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement projects.
- 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.