Talent.com
VirtualVocations
Regulatory CMC Associate DirectorVirtualVocations • North Las Vegas, Nevada, United States
Regulatory CMC Associate Director

Regulatory CMC Associate Director

VirtualVocations • North Las Vegas, Nevada, United States
3 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 • North Las Vegas, Nevada, United States

Similar jobs

Clinical Director (50028)

WestCareHenderson, NV, United States
Full-time

Henderson - 1711 Whitney Mesa - Henderson, NV 89014.Salary Position Type Full Time Job Shift Any.Person in this position will be responsible for clinical and programmatic leadership of all programs... Show more

 • Promoted

Director Quality

Hyve SolutionsLas Vegas, NV, United States
Full-time

Hyve Solutions is a leader in the data center solutions industry, designing, manufacturing, and delivering custom Server, Storage, and Networking Solutions to the world's largest Cloud, Social Medi... Show more

 • Promoted

Regional VP of Regulatory Compliance

Boyd GamingLas Vegas, NV, United States
Full-time

Regional VP of Regulatory Compliance.Boyd Gaming Corporation has been successful in gaming jurisdiction in which we operate in the United States and is one of the premier casino entertainment compa... Show more

 • Promoted

Market Director-IPM

Wellington Regional Medical CenterLas Vegas, NV, United States
Full-time

The Market Director provides leadership, direction and ongoing administration and management within a designated market for all operational aspects of Independence Physician Management's physician ... Show more

 • Promoted

Regulatory Comp Anly II

IgtLas Vegas, NV, United States
Full-time

Reporting to the supervisor or manager of Licensing, this position is responsible for the processing of occupational, individual and some corporate gaming license applications.The individual in thi... Show more

 • Promoted

Director Pharmacy Account

Elevance HealthLas Vegas, NV, United States
Full-time

This field-based role enables associates to primarily operate in the field, traveling to client sites or designated locations as their role requires, with occasional office attendance for meetings ... Show more

 • Promoted

Clinical Director

USPILas Vegas, NV, United States
Full-time

Durango Outpatient Surgery Center is seeking a motivated Clinical Director to join our established team.USPI Durango Outpatient Surgery Center is an Ambulatory Surgery Center in Las Vegas, NV.We of... Show more

 • Promoted

Regulatory Compliance Airworthiness Specialist

Allegiant TravelLas Vegas, NV, United States
Full-time +1

Regulatory Compliance Airworthiness Specialist.The Regulatory Compliance Airworthiness Specialist will assist the MGA with the completion of LOI investigations and responses, VDR investigations and... Show more

 • Promoted

Regulator Reporting Senior Consultant

DeloitteLas Vegas, NV, United States
Full-time

Regulatory Reporting Senior Consultant.Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Regulatory Reporting Senior Consu... Show more

 • Promoted

Center Director I

Octapharma PlasmaLas Vegas, NV, United States
Full-time

DescriptionHow to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader.Become one, too! Octapharma Plasma offers profess... Show more

 • Promoted

Director Environmental Compliance

GAFHenderson, NV, United States
Full-time +1

At GAF, we cover more than buildings.No matter what role, tenure, or track, under this roof you are empowered to be there for your teammates, your customers, and especially your community.Under thi... Show more

 • Promoted

Alliance Sales Executive, Associate Director - NVIDIA - FS, C&R, and TMT

EYLas Vegas, NV, United States
Full-time

Location: Anywhere in Country At EY, we're all in to shape your future with confidence.We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you ... Show more

 • Promoted

Associate Program Director

HCA HealthcareLas Vegas, NV, United States
Full-time +1

At Galen College of Nursing, we educate and empower nurses to change lives.Since 1989, we've dedicated our work to delivering high-quality nursing education with a student-first mindset.As one of t... Show more

 • Promoted

Medical Director (Utilization Management)

HJ StaffingHenderson, NV, United States
Full-time

Medical Director Of Utilization ManagementHJ Staffing is urgently seeking a Medical Director of Utilization Management to join a leading Medicare Advantage Health Plan.This physician leader will pl... Show more

 • Promoted

Medical Director - Clinical Advocacy and Support - Remote - PST preferred

UnitedHealth GroupLas Vegas, NV, United States
Full-time

Requisition number:** 2372983 **Job category:** Medical & Clinical Operations Optum is a global organization that delivers care, aided by technology to help millions of people live healthier li... Show more

 • Promoted

Director Risk Management

Direct Staffing IncLas Vegas, NV, United States
Full-time

Responsible for planning and directing the Risk Management and Loss Prevention programs from an operational perspective.Must be at least a BSN with minimum 3-5 years strong clinical experience in A... Show more

 • Promoted

Market Director-IPM

Alan B. Miller Medical CenterHenderson, NV, United States
Full-time

The Market Director provides leadership, direction and ongoing administration and management within a designated market for all operational aspects of Independence Physician Management's physician ... Show more

 • Promoted

Associate Director, Internal Tax Team - Federal Direct Tax

DeloitteLas Vegas, NV, United States
Full-time

Position Summary The Federal Direct Tax team within the US Firms Tax ("USFT") group of the Deloitte US Firms is responsible for analyzing and computing book-tax differences, calculating federal ta... Show more

 • Promoted

Market Policy Director

BHE RenewablesLas Vegas, NV, United States
Full-time

Wholesale Market Participation Manager.Directs and oversees projects, activities and deliverables associated with participation in wholesale markets.Coordinates with business units throughout Compa... Show more

 • Promoted

Director Healthcare Tech Mgmt

Veracity SolutionsLas Vegas, NV, United States
Full-time

Provides leadership and is responsible for the implementation of the UHS corporate HTM program and services.Participates in defining strategic direction of the HTM program through short and long-te... Show more