About the Role: We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections.  You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval.  The ideal candidate will have extensive analytical experience, including authoring of analytical and stability regulatory submission sections, a proven track record of excelling in a fast-paced environment, and outstanding attention to detail. 

Scope of responsibilities:

• Author and review new applications and amendments for CTD Module 3 sections S.2, S.4, S.5, and S.7 for regulatory submissions (e.g., BLAs, MAAs, INDs, IMPDs, etc).  Support responses to regulatory questions and information requests.
• Provide subject matter expertise in analytical methods, method validation, reference standard qualification, and stability studies.
• Ensure consistency, accuracy, and compliance of submission documents with current regulatory guidance and company standards.
• Remain up to date with regulatory requirements relevant to Module 3 content.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise to deliver results within project timelines.
• Proactively identify risks and propose solutions for documentation challenges.
• Lead cross-functional project meetings to support timelines and project deliverables.
• Interact and collaborate with teams to gather and interpret technical data.