Associate Director, CMC Regulatory Affairs Join to apply for the Associate Director, CMC Regulatory Affairs role at TriLink BioTechnologies, part of Maravai LifeSciences . This role offers an opportunity to provide strategic regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) across our product pipeline, especially in advanced therapies including cell and gene therapy products. Responsibilities include: Developing and implementing CMC regulatory strategies for all development phases. Guiding internal teams and clients on FDA/EMA/ICH and global regulations. Reviewing and approving regulatory documentation and contracts. Managing regulatory risks and compliance, including authoring and reviewing submissions such as INDs, CTAs, BLAs, NDAs, and MAAs. Leading documentation development for regulatory submissions and supporting regulatory interactions and inspections. Providing guidance on CMC changes, tech transfers, and manufacturing validations. Maintaining knowledge of domestic and international regulations and communicating updates to teams. Managing a team, including training and performance management. Qualifications: Bachelor's degree in a scientific discipline or equivalent. Minimum of 8 years relevant regulatory experience, with knowledge of FDA and international regulations. Experience in pharmaceutical or clinical development, especially in advanced therapies. Proven track record in preparing regulatory documentation and successful submissions. Excellent communication, teamwork, and stakeholder management skills. The position offers a salary range of $156,000 - $172,000 plus incentives and benefits, with details available on the company's career site. Maravai LifeSciences is an Equal Opportunity Employer. Be aware of scam alerts and only communicate through official channels. #J-18808-Ljbffr TriLink BioTechnologies, LLC
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