Aadi Bioscience, Inc · 4 days ago
Senior Manager, CMC Regulatory Affairs
United States
Full-time
Hybrid
Mid, Senior Level
$170K/yr - $170K/yr
3+ years expAadi Bioscience, Inc. is focused on developing precision medicines for rare genomic alteration-driven cancers. They are seeking a Senior Manager in CMC Regulatory Affairs to implement global regulatory strategies for drug products throughout their lifecycle, ensuring compliance with regulatory authorities in the US and EU.
BiopharmaBiotechnologyLife ScienceOncology
Responsibilities
Develop, lead and implement US/EU and additional regions as applicable CMC regulatory strategies across product lifecycle from early development through approval and post-approval change management
Provide strategic regulatory guidance and risk assessments to cross-functional teams (CMC development, quality, manufacturing, clinical) to align product development with regulatory expectations
Plan, author, review, coordinate and submit CMC sections of regulatory documentation, including INDs, IMPDs/CTAs, BLAs/NDAs/MAAs and amendments for both US and EU authorities
Prepare briefing documents, meeting requests, responses to Health Authority questions and lead CMC regulatory agency meetings as needed (e.g., FDA and EMA)
Monitor and communicate relevant regulatory guidelines, policy changes, ICH expectations, and quality directives affecting CMC requirements in US, EU and international regions
Evaluate the regulatory impact of manufacturing changes, quality system updates, GMP compliance issues, and ensure alignment of CMC documentation with current regulations
Lead post-approval CMC change control assessments, regulatory impact analyses, and submission planning (e.g., supplements, variations)
Develop and maintain strategies for lifecycle management, ensuring necessary filings for changes to processes, controls or specifications are executed appropriately
Liaise with quality assurance, manufacturing, technical operations and external partners/CMOs to align regulatory expectations with operational execution
Ensure CMC sections of regulatory submissions are high quality, accurate, complete and compliant with eCTD and other format requirements
Support the development and maintenance of internal regulatory processes, SOPs and best practices relevant to CMC regulatory affairs
Point of contact with regional regulatory authorities as appropriate in the capacity of the CMC regulatory expert
Respond to Regulatory Authority requests for information
Establish accurate plans and timelines for CMC sections of regulatory submissions
Work closely with Regulatory Operations to ensure CMC documents are of high quality and meet the requirements for inclusion in electronic or paper submissions as appropriate
Familiarity with Veeva RIM implementation and document migration
Responsible for accurate and timely archiving of all regulatory affairs documentation including agency correspondence and submitted sequences into regulatory information management system as well as tracking of global regulatory submissions
Qualification
Required
Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Biochemistry or related discipline required
Generally 3 – 5+ years of progressive experience in CMC Regulatory Affairs within biotech or pharmaceutical industry
Proven track record with CMC submission authoring and strategy for US (FDA) and EU (EMA/Member States) regulatory authorities
Detailed knowledge of US and EU CMC regulatory requirements
Working familiarity of electronic regulatory submission requirements
Ability to work collaboratively and productively in a diverse, continually changing, and team-oriented organization
Ability to work independently with internal and external stakeholders at various levels
Excellent organizational, facilitation, and communication skills
Self-motivated and able to work from a home office environment
Practical knowledge of MS Word, Excel, PowerPoint, and project management software
Preferred
Advanced degree (MS/PhD) preferred
Past work experience in a technical CMC discipline (e.g. manufacturing, product development, analytical development or QC is an advantage but not required)
Prior work in small or medium biotech environments (including working with CMOs, consultants and cross-border regulatory requirements) is advantageous
Benefits
Medical, dental, and vision insurance
A 401(k) plan with company match
Paid time off (PTO)
Paid holidays
Parental leave
Company
Aadi Bioscience, Inc
Aadi Bioscience Inc. (Aadi) is a biopharmaceutical company focused on precision therapies for genetically-defined cancers.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$350.5MKey Investors
Ally Bridge GroupHermed Capital
2025-03-04Post Ipo Equity· $100M
2022-09-22Post Ipo Equity· $72.5M
2021-08-27IPO
Leadership Team
Brendan Delaney
President and CEO at Aadi Bioscience
Recent News
2025-11-25
DelveInsight Business Research LLP
2025-10-13
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