Job Closed
This listing is no longer active.
Director, CMC Regulatory
Location
Colorado + 1 moreAll locations: Colorado | Washington
Posted
93 days ago
Salary
$206.4K - $254.9K / year
Seniority
Lead
Job Description
Director, CMC Regulatory
Umoja BioPharma
• Provide technical regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs • Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings • Lead technical modules and sections of global regulatory filings (IND/CTA/BLA/MAA submissions) • Interact with regulatory agencies and represent Regulatory CMC at HA meetings • Provide phase-appropriate strategic guidance/input related to current regulatory requirements for clinical trial applications and marketing applications • Coordinate, manage, and lead all CMC regulatory projects including management of budget, timelines, and submission planning • Ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports • Independently manage and prioritize Phase 1 IND through late-stage projects • Identify, communicate, and propose resolutions to routine and complex issues • Provide regulatory advice and guidance in the context of available scientific data • Collaborate closely with global regulatory lead, translational medicine, preclinical, clinical, and technical teams
Job Requirements
- PhD/MS/BA in a relevant scientific field of study required with a minimum of 10/12/15 years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry
- Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities
- Strong knowledge of global CMC regulatory requirements for early- and late-stage development of gene and cell therapies
- Proven ability to interact with regulatory authorities
- Excellent communication, leadership, and cross-functional collaboration skills
- Passion for innovation and commitment to advancing transformative therapies for patients
Benefits
- Competitive Medical, Dental, and Vision plans
- 401k plan through Fidelity, with a 100% match up to their first 4% deferral
- Generous Paid Time Off policy
- Employee commuter benefits
- Cell phone stipend
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Avint is hiring an ISSO (Cybersecurity Compliance Specialist / RMF) to support cybersecurity compliance and risk management efforts within the HACS program at FRTIB HQ. In this role, you’ll help maintain system authorization, develop security documentation, and ensure systems meet federal cybersecurity standards.
Avint is hiring a Senior ISSO (Cybersecurity Compliance Lead / RMF SME) to support and protect critical federal systems within the HACS program at FRTIB HQ. In this role, you’ll be part of a high-performing team leading Risk Management Framework (RMF) and Authority to Operate (ATO) efforts across mission-critical systems. You’ll work at the intersection of cybersecurity, compliance, and mission operations, ensuring systems are secure, authorized, and aligned with federal requirements
Program Project Specialist
Arizona Department of AdministrationThe Attorney General's Office offers a comprehensive benefits package. For a complete list of benefits provided by The State of Arizona, please visit our benefits page.
Role Description This Program Project Specialist serves an integral role within the Compliance team of the Arizona Barbering & Cosmetology Board. This position provides a wide range of support to the Compliance team, including: - Data entry - Reviewing and analyzing applicable Arizona Administrative Code and Arizona Revised Statutes - Developing methods for improvement of operations - Researching and compiling information - Developing forms - Preparing reports This position may be available for remote work within Arizona (1-3 days per week in the office/hoteling). Qualifications - Knowledge of applicable program regulations, objectives, standards, and procedures - Knowledge of management and procedures analysis techniques and principles - Skills in oral and written communication - Ability to develop procedures, analyze problems, and design effective plans for program improvement Requirements - Drafts high-level correspondence, in coordination with Investigators, for Board Members and the license holders - Review, analyze, and input inspection report into Arizona Barbering & Cosmetology IT Systems - Investigates, researches, and documents pertinent rules and laws for investigative reporting - Drafts and responds to emails and phone calls from license holders Benefits - Optional employee benefits include short-term disability insurance, deferred compensation plans, and supplemental life insurance - Life insurance and long-term disability insurance - Vacation with 10 paid holidays per year - Health and dental insurance - Retirement plan - Sick leave - Learn more about the Paid Parental Leave pilot program here . - Positions in this classification participate in the Arizona State Retirement System (ASRS) - Please note, enrollment eligibility will become effective after 27 weeks of employment Contact Us If you have any questions, please feel free to contact Shawn McConnell at shawn.Mcconnell@azdoa.gov for assistance.
Compliance Associate
PaxosPaxos is a regulated blockchain infrastructure company building transparent and transformative financial solutions.
• Monitor activity across Paxos‑issued stablecoins using blockchain analytics tools, triaging alerts and escalating higher‑risk activity to senior investigators as appropriate. • Conduct first‑line investigations into potential suspicious activity, synthesizing KYC, transactional, and open‑source information into clear case files and recommendations. • Support quarterly forensic reviews of stablecoin transactions to identify trends, typologies, and emerging risks, documenting findings for leadership and auditors. • Assist with the intake and management of internal referrals, collaborating with real‑time monitoring, product, legal, and other cross‑functional stakeholders to resolve complex cases. • Help maintain information‑sharing workflows with law enforcement agencies, regulators, and industry partners, ensuring timely and well‑documented responses. • Draft clear, well‑structured investigation summaries, SAR/STR supporting documentation, and case narratives that meet regulatory and internal quality standards. • Use AI tools to speed up investigative workflows (e.g., triage, data summarization, drafting), while maintaining ownership and accountability for final decisions and outputs. • Contribute to continuous improvement of procedures, playbooks, and training materials for transaction monitoring, investigations, and reporting. • Participate in the team’s rotating weekend/on‑call coverage and occasional travel to support training, audits, or regulatory meetings, as needed for the role.

