Director, CMC Regulatory Affairs
The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189
Job Title
Director, CMC Regulatory Affairs
Job Number
37269
Location
San Diego, CA 92121
Job Description
The Director of CMC Regulatory Affairs leads the strategy and execution of all Chemistry, Manufacturing, and Controls (CMC) regulatory activities throughout the product lifecycle. This role is primarily responsible for guiding through the Biologics License Application (BLA) process and supporting the progression of additional pipeline programs from development through potential commercialization and post-approval commitments.
Working closely with and reporting to the VP of Regulatory Affairs, the Director shapes and implements CMC regulatory strategies, ensures compliance with global regulatory standards (including FDA, ICH, and EMA requirements), proactively manages regulatory risks, and collaborates cross-functionally with teams such as CMC Development, Manufacturing, Quality, MSAT, and Supply Chain. The position plays a critical role in delivering successful regulatory submissions, managing health authority interactions, and advancing company goals within a dynamic, mission-focused biotech setting.
Responsibilities
Lead and implement the global CMC regulatory strategy throughout the entire product lifecycle—from early development through commercialization and post-approval—ensuring alignment with worldwide regulatory standards and broader regulatory and business objectives.
Direct the preparation, writing, review, approval, assembly, and submission of CMC components for key regulatory filings, including IND amendments, BLA modules, supplements, annual reports, MAAs, responses to agency questions, and post-approval changes.
Anticipate and mitigate risks related to documentation quality, content accuracy, and submission timelines for global CMC filings by partnering closely with Manufacturing, Quality, Process Development, MSAT, and other functions to secure timely, high-quality technical documentation.
Review and approve CMC-related materials requiring Regulatory Affairs oversight, such as change controls, regulatory impact assessments, technical reports, stability protocols, validation summaries, comparability plans, and deviation or investigation reports.
Promote cross-functional alignment and phase‑appropriate CMC readiness by working with Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, and other teams to support development, scale‑up, validation, and commercial launch preparedness.
Review and approve product labeling with accountability for CMC‑related content, including product descriptions and manufacturing statements, and contribute to Advertising and Promotion review committees when needed.
Lead, mentor, and develop Regulatory Affairs team members, providing guidance, accountability, and support to drive strong performance and professional growth.
Act as the primary CMC liaison to regulatory agencies—primarily the FDA for biologics and cell therapies, and potentially the EMA—managing submissions, negotiations, formal meetings (such as Type meetings and pre‑BLA discussions), and responses to agency inquiries or deficiencies, including CMC‑related items.
Stay informed of evolving global regulations, guidance, and industry precedents (e.g., ICH updates, FDA CMC guidance for cell and gene therapies, advanced therapy regulations) and proactively adjust CMC strategies to ensure compliance and maintain a competitive edge.
Support regulatory risk evaluations, gap assessments, contingency planning, and inspection readiness activities related to CMC and manufacturing operations.
Carry out additional responsibilities as assigned.
Required Skills
A bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a related discipline is required; an advanced degree such as an MS, PhD, or PharmD is strongly preferred.
At least 8 years of regulatory affairs experience within the pharmaceutical or biotech industry, with a strong emphasis on CMC. Significant experience with biologics, cell therapies, or regenerative medicine products is required, and experience supporting commercial products and post‑approval lifecycle management is highly desirable.
Demonstrated success in preparing, leading, and submitting CMC components for major regulatory applications (e.g., INDs, BLAs, NDAs, MAAs, supplements) to the FDA and/or EMA, including effectively addressing agency questions, deficiencies, and Complete Response Letters.
Deep understanding of global CMC regulatory standards and guidance for biologics and cell therapies, including ICH Q8–Q12 and FDA guidance related to cellular therapies, process validation, stability, comparability, and potency testing.
Experience contributing to BLA or comparable filings for advanced therapy products, with preferred experience managing CMC considerations during late‑stage reviews or post‑CRL situations.
Strong project management capabilities, with the ability to oversee multiple complex initiatives, coordinate cross‑functional efforts, and manage timelines and resources in a fast‑moving environment.
Excellent written and verbal communication skills, including the ability to draft clear regulatory documentation, present regulatory strategies, and interact effectively with internal teams, external partners, and regulatory agencies.
Familiarity with regulatory information management systems and document publishing tools (e.g., Veeva RIM and related platforms).
Proven leadership skills, including mentoring and developing team members, encouraging collaboration, and promoting accountability.
Ability to think strategically, work independently, and succeed in a collaborative, high‑energy setting.
Work Environment / Physical Requirements
Primarily office‑based, with responsibilities focused on regulatory documentation, strategic planning, and coordination across functions and global teams.
Extended periods of computer use are required for drafting, reviewing, compiling, and managing CMC documentation and submissions.
May occasionally need to lift office materials weighing up to 15 pounds.
Ability to function in a standard office setting and travel periodically for regulatory meetings, agency interactions, inspections, or industry conferences, as needed.
Salary $175‑220K plus benefits
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Director, CMC Regulatory Affairs
Job Number
37269
Location
San Diego, CA 92121
Job Description
The Director of CMC Regulatory Affairs leads the strategy and execution of all Chemistry, Manufacturing, and Controls (CMC) regulatory activities throughout the product lifecycle. This role is primarily responsible for guiding through the Biologics License Application (BLA) process and supporting the progression of additional pipeline programs from development through potential commercialization and post-approval commitments.
Working closely with and reporting to the VP of Regulatory Affairs, the Director shapes and implements CMC regulatory strategies, ensures compliance with global regulatory standards (including FDA, ICH, and EMA requirements), proactively manages regulatory risks, and collaborates cross-functionally with teams such as CMC Development, Manufacturing, Quality, MSAT, and Supply Chain. The position plays a critical role in delivering successful regulatory submissions, managing health authority interactions, and advancing company goals within a dynamic, mission-focused biotech setting.
Responsibilities
Lead and implement the global CMC regulatory strategy throughout the entire product lifecycle—from early development through commercialization and post-approval—ensuring alignment with worldwide regulatory standards and broader regulatory and business objectives.
Direct the preparation, writing, review, approval, assembly, and submission of CMC components for key regulatory filings, including IND amendments, BLA modules, supplements, annual reports, MAAs, responses to agency questions, and post-approval changes.
Anticipate and mitigate risks related to documentation quality, content accuracy, and submission timelines for global CMC filings by partnering closely with Manufacturing, Quality, Process Development, MSAT, and other functions to secure timely, high-quality technical documentation.
Review and approve CMC-related materials requiring Regulatory Affairs oversight, such as change controls, regulatory impact assessments, technical reports, stability protocols, validation summaries, comparability plans, and deviation or investigation reports.
Promote cross-functional alignment and phase‑appropriate CMC readiness by working with Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, and other teams to support development, scale‑up, validation, and commercial launch preparedness.
Review and approve product labeling with accountability for CMC‑related content, including product descriptions and manufacturing statements, and contribute to Advertising and Promotion review committees when needed.
Lead, mentor, and develop Regulatory Affairs team members, providing guidance, accountability, and support to drive strong performance and professional growth.
Act as the primary CMC liaison to regulatory agencies—primarily the FDA for biologics and cell therapies, and potentially the EMA—managing submissions, negotiations, formal meetings (such as Type meetings and pre‑BLA discussions), and responses to agency inquiries or deficiencies, including CMC‑related items.
Stay informed of evolving global regulations, guidance, and industry precedents (e.g., ICH updates, FDA CMC guidance for cell and gene therapies, advanced therapy regulations) and proactively adjust CMC strategies to ensure compliance and maintain a competitive edge.
Support regulatory risk evaluations, gap assessments, contingency planning, and inspection readiness activities related to CMC and manufacturing operations.
Carry out additional responsibilities as assigned.
Required Skills
A bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a related discipline is required; an advanced degree such as an MS, PhD, or PharmD is strongly preferred.
At least 8 years of regulatory affairs experience within the pharmaceutical or biotech industry, with a strong emphasis on CMC. Significant experience with biologics, cell therapies, or regenerative medicine products is required, and experience supporting commercial products and post‑approval lifecycle management is highly desirable.
Demonstrated success in preparing, leading, and submitting CMC components for major regulatory applications (e.g., INDs, BLAs, NDAs, MAAs, supplements) to the FDA and/or EMA, including effectively addressing agency questions, deficiencies, and Complete Response Letters.
Deep understanding of global CMC regulatory standards and guidance for biologics and cell therapies, including ICH Q8–Q12 and FDA guidance related to cellular therapies, process validation, stability, comparability, and potency testing.
Experience contributing to BLA or comparable filings for advanced therapy products, with preferred experience managing CMC considerations during late‑stage reviews or post‑CRL situations.
Strong project management capabilities, with the ability to oversee multiple complex initiatives, coordinate cross‑functional efforts, and manage timelines and resources in a fast‑moving environment.
Excellent written and verbal communication skills, including the ability to draft clear regulatory documentation, present regulatory strategies, and interact effectively with internal teams, external partners, and regulatory agencies.
Familiarity with regulatory information management systems and document publishing tools (e.g., Veeva RIM and related platforms).
Proven leadership skills, including mentoring and developing team members, encouraging collaboration, and promoting accountability.
Ability to think strategically, work independently, and succeed in a collaborative, high‑energy setting.
Work Environment / Physical Requirements
Primarily office‑based, with responsibilities focused on regulatory documentation, strategic planning, and coordination across functions and global teams.
Extended periods of computer use are required for drafting, reviewing, compiling, and managing CMC documentation and submissions.
May occasionally need to lift office materials weighing up to 15 pounds.
Ability to function in a standard office setting and travel periodically for regulatory meetings, agency interactions, inspections, or industry conferences, as needed.
Salary $175‑220K plus benefits
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