Job Description The job that makes possibilities real in patients' lives. And yours. The job that helps you get ahead in life. Moving mountains together. Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place Moving mountains together – as Senior Manager CMC Dossier Strategy & Leadership (all genders) (permanent / full-time) This position ensures that global regulatory dossiers are aligned with current AbbVie’s CMC best practices. The role works with CMC teams during the development of cutting-edge control strategies and influences in generating data packages that support the CMC control strategy. The role authors narrative sections of CTDs to communicate a single, integrated strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content. Responsibilities 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. Provides real-time input on source document preparation to ensure a submission-ready data set is generated. Actively contributes and/or leads team discussion on control strategy topics, actively participates in control strategy reviews (CSR) and regulatory strategy (story-boarding) as part of the CMC team. Primary author of narrative-rich sections of INDs and MAAs to ensure a single, consistent story is communicated to health authorities. Reviews data-rich sections of INDs and MAAs to ensure content alignment across the submission. Ensures timely delivery of dossiers to meet regulatory submission timelines Authors regulatory query responses and contributes to briefing books. Attend meetings of interactions with agencies on CMC topics Serves as an internal SME for technical topics across the portfolio (for example, mutagenic impurities, gross content control, etc). Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement processes. Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities, gaps and synergies consistent with project strategy. Actively mediates internal team disputes, and facilitates establishment of high performing teams.