Compliance Director
TradeJobsWorkForce92702 Santa Ana, CA, USFull-time
Compliance Director Job Duties: Accomplishes compliance human resource strategies by determining acco... Show more
Regulatory CMC Associate DirectorVirtualVocations • Downey, California, United States
No longer accepting applications
Regulatory CMC Associate Director
VirtualVocations • Downey, California, United States
4 days ago
Job type
- Full-time
Job description
Hands-on and strategic, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product global regulatory CMC strategies for investigational products, manage regulatory submissions, and provide guidance to cross-functional teams while working remotely. Key responsibilities: Leads the preparation and review of CMC sections of global regulatory submissions and manages interactions with regulatory agencies Defines CMC content requirements for regulatory submissions and ensures compliance with established regulations Stays updated on evolving regulatory CMC requirements and provides guidance to cross-functional teams on compliance topics Required qualifications: Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Regulatory Affairs) Minimum 10 years of experience in the vaccine or biotech industry, or equivalent combination of education and experience Prior experience preparing/authoring CMC DS sections, with BLA and IND experience highly preferred Advanced knowledge of regulatory guidelines (FDA, EMA, Health Canada, ICH) Strong strategic thinking and problem-solving skills
Create a job alert for this search
Regulatory CMC Associate Director • Downey, California, United States
Similar jobs
Laboratory Director
US FertilityNewport Beach, CA, United StatesFull-time +1
Build What Matters MostFamilies, Futures, and Your Career.Enjoy meaningful work while contributing to an organization that changes lives every day.US Fertility, the nation's leading partnership of ... Show more
Director of Quality of Mgmt
AHMC Healthcare Inc.San Gabriel, CA, United StatesFull-time
Quality, Risk, And Patient Satisfaction Director.Responsible for the overall administration and direction of quality, risk, and patient satisfaction functions.Plans and coordinates services and ope... Show more
Director, External Quality Assurance (GMP)
XencorPasadena, CA, United StatesFull-time
Director, External Quality Assurance (GMP).Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego.Our focus is developing high-pote... Show more
Director, Manufacturing Engineering, Intelligence Systems
Anduril IndustriesCosta Mesa, CA, United StatesFull-time
Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the def... Show more
Associate Director, Space
AndurilCosta Mesa, CA, United StatesFull-time
Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the def... Show more
Tax Strategy Director - ASC 740 & Compliance Leader
East West BankPasadena, CA, United StatesFull-time
East West Bank in Pasadena, California, is seeking a Director of Tax to oversee the bank’s tax function, manage tax compliance, and lead tax audits.The role requires a Bachelor's degree in Accounti... Show more
Associate Director/Manager, Field Medical Affairs
Dendreon PharmaceuticalsSeal Beach, CA, United StatesFull-time
Associate Director/Manager, Field Medical Affairs.At Dendreon, we're transforming the battle against cancer with personalized immunotherapy.Our flagship product, PROVENGE (sipuleucel-T), was the fi... Show more
Associate Director, Category Insights
Lee Kum Kee USACity Of Industry, CA, United StatesFull-time
Associate Director, Category Insights.Ready to bring fresh energy to your career? At Lee Kum Kee, we're committed to growth, offering a place where creativity and innovation thrive.If you're eager ... Show more
Sr. Director, Clinical Science (Oncology)
XencorPasadena, CA, United StatesFull-time
Director, Clinical Science (Oncology).Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego.Our focus is developing high-potential... Show more
Regulatory Affairs Officer
Western Asset ManagementPasadena, CA, United StatesFull-time
At Franklin Templeton, we believe success is built through powerful partnerships.As a forward thinking asset manager, we build dynamic relationships with clients, understand their goals, and naviga... Show more
Regulatory Compliance Manager
DHD ConsultingBuena Park, CA, United StatesFull-time
Buena Park, California, United States.About the Job Regulatory Compliance Manager.Provide regulatory leadership to cross-functional teams on existing and new regulations of FDA/USDA/CFIA labeling c... Show more
Director, Manufacturing Engineering, Intelligence Systems
Dormont Manufacturing CoCosta Mesa, CA, United StatesFull-time
Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the def... Show more
Senior Tax Director, Law Firm Leadership
O'Melveny & Myers LLPNewport Beach, CA, United StatesFull-time
O'Melveny & Myers LLP is seeking an experienced Tax Director to lead its tax compliance and strategy efforts in Newport Beach.The candidate will ensure compliance with tax laws while developing tax... Show more
Director, Lab Services - AMC - F/T - Days
UC IrvineOrange, CA, United StatesFull-time
UCI Health is one of California's largest academic health systems and the clinical enterprise of the University of California, Irvine.Established on July 1, 1976, UCI Health has grown into a 1,461-... Show more
Director, Continuous Improvement
SafranGarden Grove, CA, United StatesFull-time +2
Director, Continuous Improvement **Job details** **General information** **Entity** Safran is an international high-technology group operating in the fields of aerospace (propulsion, equipment ... Show more
Account Mgmt Medical Director RVP
Elevance HealthCosta Mesa, CA, United StatesFull-time
Account Mgmt Medical Director RVP.Account Management Medical Director RVP.Location: May be located in any Elevance Health Pulse Point office locations preferably in Costa Mesa, CA, Walnut Creek, CA... Show more
Director Quality Ethics & Compliance
ScionHealthWest Covina, CA, United StatesFull-time
Performance Improvement Program Manager.Kindred Hospital San Gabriel Valley is a 76-bed long-term acute care hospital offering the same in-depth care you would receive in a traditional hospital, bu... Show more
Associate Director of Development, Anti-Cancer Challenge
UC IrvineOrange, CA, United StatesFull-time
Associate Director of Development, Anti-Cancer Challenge.Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 publi... Show more
Senior Manager, Regulatory Strategy
Identified Talent SolutionsAzusa, CA, United StatesFull-time
Senior Manager, Regulatory Strategy.Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the bu... Show more