Manager, CMC Regulatory Affairs
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
Overview
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
Responsibilities
Support the development and execution of CMC regulatory strategy across the product lifecycle (development through commercial and post-approval) to ensure regulatory compliance and alignment with global requirements
Lead the preparation, authoring, review, compilation, and submission of CMC sections for regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, responses to information requests, and post-approval changes)
Collaborate with internal CMC, Manufacturing, Quality Assurance, Process Development, and other supporting departments to ensure timely generation, review, and approval of source documents required for regulatory submissions (e.g., stability data, comparability protocols, process validation reports)
Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, validation master plans, and deviation investigations
Interface directly with health authorities (primarily FDA, potentially EMA) for CMC-related submissions, negotiations, meetings (e.g., Type meetings, pre-submission interactions), and responses to queries or deficiencies (including addressing any outstanding CMC items from prior BLA feedback)
Monitor evolving global regulatory changes, guidelines, and precedents (e.g., ICH updates, FDA biologics guidance for cell therapies) and assess impacts on Capricor projects, providing proactive recommendations to leadership
Contribute to regulatory risk assessments, gap analyses, and contingency planning for CMC aspects of submissions and lifecycle management
Support inspection readiness activities related to CMC documentation and manufacturing sites
Perform such other duties as may be assigned from time to time
Requirements
Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred
5+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, preferably for biologics, cell therapies, or advanced therapy medicinal products (ATMPs)
Demonstrated experience preparing, authoring, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including responses to agency queries
Solid knowledge of global regulatory requirements and guidelines relevant to CMC for biologics/cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, comparability, process validation, stability)
Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or Complete Response Letters preferred
Strong project management skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment
Excellent communication skills (written and verbal) for effective interaction with internal stakeholders, external partners, and health authorities
Proficiency in regulatory document management systems and tools (e.g., Veeva RIM, document authoring software)
Ability to work independently while collaborating cross-functionally with scientific, manufacturing, and quality teams
Work Environment / Physical Demands
Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional coordination
Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions
May involve lifting office materials up to 15 pounds
Ability to navigate standard office environments and travel occasionally for regulatory meetings, health authority interactions, or site visits (as needed)
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
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Responsibilities
Support the development and execution of CMC regulatory strategy across the product lifecycle (development through commercial and post-approval) to ensure regulatory compliance and alignment with global requirements
Lead the preparation, authoring, review, compilation, and submission of CMC sections for regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, responses to information requests, and post-approval changes)
Collaborate with internal CMC, Manufacturing, Quality Assurance, Process Development, and other supporting departments to ensure timely generation, review, and approval of source documents required for regulatory submissions (e.g., stability data, comparability protocols, process validation reports)
Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, validation master plans, and deviation investigations
Interface directly with health authorities (primarily FDA, potentially EMA) for CMC-related submissions, negotiations, meetings (e.g., Type meetings, pre-submission interactions), and responses to queries or deficiencies (including addressing any outstanding CMC items from prior BLA feedback)
Monitor evolving global regulatory changes, guidelines, and precedents (e.g., ICH updates, FDA biologics guidance for cell therapies) and assess impacts on Capricor projects, providing proactive recommendations to leadership
Contribute to regulatory risk assessments, gap analyses, and contingency planning for CMC aspects of submissions and lifecycle management
Support inspection readiness activities related to CMC documentation and manufacturing sites
Perform such other duties as may be assigned from time to time
Requirements
Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) preferred
5+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, preferably for biologics, cell therapies, or advanced therapy medicinal products (ATMPs)
Demonstrated experience preparing, authoring, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including responses to agency queries
Solid knowledge of global regulatory requirements and guidelines relevant to CMC for biologics/cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, comparability, process validation, stability)
Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or Complete Response Letters preferred
Strong project management skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment
Excellent communication skills (written and verbal) for effective interaction with internal stakeholders, external partners, and health authorities
Proficiency in regulatory document management systems and tools (e.g., Veeva RIM, document authoring software)
Ability to work independently while collaborating cross-functionally with scientific, manufacturing, and quality teams
Work Environment / Physical Demands
Primarily office-based with tasks involving regulatory documentation, strategy development, and cross-functional coordination
Requires prolonged periods of computer use for drafting, reviewing, compiling, and reporting on CMC documents and submissions
May involve lifting office materials up to 15 pounds
Ability to navigate standard office environments and travel occasionally for regulatory meetings, health authority interactions, or site visits (as needed)
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
#J-18808-Ljbffr