Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/abbvie). 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. Qualifications - Bachelor's with 10, Masters with 8, or PhD with 5 years of CMC functional experience including late-stage development experience - Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc) translating experimental work into at-scale drug substance or drug product manufacturing. - Technical writing experience communicating experimental development work, preferably including though contributions to INDs or marketing applications. - Experience contributing to cross-functional technical teams Here's how we can move mountains together - with a diverse work environment where you can have a real impact - with an open corporate culture - with an attractive salary - with an intensive onboarding process with a mentor at your side - with flexible work models for a healthy work-life balance - with a corporate health management that offers comprehensive health and exercise programs - with company social benefits - with a wide range of career opportunities in an international organization - with top-tier, attractive development opportunities - with a strong international network Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) - a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect. At AbbVie, your individual contributions count - help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application All you need is a complete CV - we will discuss everything else with you in person. Have questions? Email talentacquisition.deabbvie.com - we look forward to hearing from you Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html