Manager, Regulatory CMC

Job Description

Obtain and manage CMC-related documents for regulatory submissions. Ensure compliance with ICH, FDA, EMA, WHO, and other regulatory guidelines. Collaborate with internal teams and CMOs to prepare high-quality regulatory sections. Lead responses to CMC-related questions from regulatory authorities. Establish strategies for document authoring and quality. Implement industry standards for regulatory submissions. Communicate unified regulatory messages at interdisciplinary meetings. Identify and mitigate regulatory CMC risks. Promote continuous improvement within regulatory compliance. Ensure efficient and transparent working environment within GRA. Other tasks as required by senior management. Job Requirements: Bachelor s or master s degree in biotechnology, Life Sciences. 5+ years direct industry experience in Regulatory CMC Biologics, 10+ years industry-relevant experience. Hands-on experience with EMA/FDA/PMDA/Health Canada CTD requirements. Proven ability to produce high-quality CMC documentation for complex large molecules. Knowledge of CMC expectations at all stages of product development. Experience with post-market activities in the LCM space preferred. Strong communication and interpersonal skills. Ability to work independently and prioritize tasks effectively. Proficiency in English, written and spoken. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment.