Katalyst HealthCares and Life SciencesMatthews, NC, US
Full-time
The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory ...Show moreLast updated: 10 hours ago
Promoted
Regulatory Project Manager (Energy)
Ember Group ConsultingCharlotte, NC, United States
Full-time
Fuel Your Passion and Spark Your Potential at Ember Group Consulting.Join a vibrant community of passionate individuals who share your drive to make a real impact.
At Ember Group Consulting, we beli...Show moreLast updated: 13 days ago
Regulatory Attorney
Fast Track HiringCharlotte, North Carolina, United States
Full-time
We are representing a well-established legal firm with a nationally recognized financial regulatory practice seeking a motivated attorney to join their team.
This role centers on bank regulatory law...Show moreLast updated: 21 days ago
Regulatory Remediation Manager
Ally601 S. Tryon Street, NC, United States
Full-time +1
At Ally, you get a startup feel, but experience the benefits of a company that has worked out the kinks and is fulfilling its purpose.
We are always evolving and see that as a good thing.From owning...Show moreLast updated: 24 days ago
Financial Regulatory Reporting Manager
Wells FargoCharlotte, United States
Full-time +1
See job description for details.Wells Fargo is seeking a Financial Regulatory Reporting Manager with SME knowledge and experience of Counterparty specific reports specifically the FFIEC009, FR2510 ...Show moreLast updated: 9 days ago
Promoted
Audit Manager - Regulatory Issue Validation
USAACharlotte, NC, US
Full-time
At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice.
We seek to be the #1 choice for the military...Show moreLast updated: 7 days ago
Regulatory Reporting Governance, Manager
SoFiCharlotte, NC
Full-time
The SoFi Regulatory Reporting Governance Manager is a collaborative, well-organized, action-oriented individual with exceptional leadership and time management skills, confident in presenting, faci...Show moreLast updated: 4 days ago
Senior Manager, Regulatory Affairs
Katalyst HealthCares & Life SciencesCharlotte, NC
Full-time
The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory ...Show moreLast updated: 4 days ago
Regional Regulatory Specialist
Flourish ResearchMatthews, North Carolina, USA
Full-time
Flourish Research is looking for motivated talented creative individuals who want to learn and grow in their careers while contributing to research that changes lives!.
We offer an excellent compreh...Show moreLast updated: 2 days ago
Regulatory Intelligence Manager
Navex GlobalCharlotte, NC, United States
Full-time
It's fun to work in a company where people truly BELIEVE in what they're doing!We're committed to bringing passion and customer focus to the business.
At NAVEX, we're making the world a better place...Show moreLast updated: 30+ days ago
Altius Talent | Freight Forwarding RecruitmentCharlotte, NC, US
Full-time
Trade Compliance Manager – Regulatory Affairs – Charlotte, NC (Hybrid).Customs, HTS classification, licensed customs broker, import / export regulations, Charlotte hybrid.
European roots and a strong ...Show moreLast updated: 28 days ago
Promoted
Coordinator - Oncology Research Regulatory Affairs & Compliance
Advocate Aurora HealthCharlotte, NC, US
Full-time
Carolinas Medical Center - LC : Clinical Trials : Morehead.Schedule Details / Additional Information : .Coordinates the clinical, regulatory, business, and other research- related activities and document...Show moreLast updated: 6 days ago
Promoted
Regulatory Specialist
ACE PartnersCharlotte, NC, United States
Full-time
This role is responsible for ensuring regulatory compliance by managing recalls, medical device reports (MDRs / MPRs), and critical complaints.
The Specialist will lead regulatory submissions, liaise ...Show moreLast updated: 20 days ago
Regulatory Change Implementation Manager
TDCharlotte, North Carolina
Full-time
At TD Bank US Compliance, we're on a mission to build a more resilient and scalable compliance risk management function.As part of our team, you'll play a key role in reshaping compliance structure...Show moreLast updated: 19 days ago
Promoted
Senior Manager, Regulatory Affairs
VirtualVocationsCharlotte, North Carolina, United States
Full-time
A company is looking for a Senior Manager, Global Regulatory Project Management and Strategic Planning.Key Responsibilities Partner with Global Regulatory Lead on project plans and execute Global...Show moreLast updated: 3 days ago
At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleague...Show moreLast updated: 4 days ago
Regulatory Reporting Senior Manager
Huntington National BankOne South Charlotte Nc
Full-time
At the direction of the Head of Regulatory Reporting, our Regulatory Reporting Senior Manager will have primary responsibility for managing short term and long term, complex regulatory reporting re...Show moreLast updated: 30+ days ago
Halliburton is hiring : Regulatory Affairs Professional / Hazard Communication in C
HalliburtonCharlotte, NC, United States
Full-time +1
We are looking for the right people — people who want to innovate, achieve, grow and lead.We attract and retain the best talent by investing in our employees and empowering them to develop themselv...Show moreLast updated: 30+ days ago
Halliburton is hiring : Regulatory Affairs Professional / Hazard Communication in C
MediabistroCharlotte, NC, United States
Full-time +1
We are looking for the right people — people who want to innovate, achieve, grow and lead.We attract and retain the best talent by investing in our employees and empowering them to develop themselv...Show moreLast updated: 30+ days ago
Katalyst HealthCares and Life SciencesMatthews, NC, US
10 hours ago
Job type
Full-time
Job description
Responsibilities :
The Senior Manager, Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings.
This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to meet technical writing and submission management objectives.
Support the CMC regulatory writing for high-quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, NDAs and their amendments / variations / supplements, as applicable) within defined timelines.
Support Regulatory CMC submission management.
Support determination of regulatory and scientific / technical requirements for CMC submissions.
Maintain knowledge of CMC regulatory requirements for drug development through post-approval and annual updated.
Requirements :
BS in Chemistry, Pharmaceutical Sciences, Regulatory Affairs or other relevant fields.
3 - 5 years of experience in authoring CMC sections of regulatory filings.
Demonstrated competency in clear and concise technical writing ability.
Understanding of CMC manufacturing documentation requirements.
Experience with regulatory submissions and requirements, including eCTD documents required for INDs, NDAs and MAAs, supplements and briefing documents.
Ability to read and interpret regulations and guidance.
Excellent team interaction skills and ability to work successfully in a cross-functional team.
Ability to work in a dynamic environment with a high degree of flexibility.
Independent management of projects.
Well organized, flexible, and able to communicate effectively within CMC functions and Regulatory affairs, both spoken and in writing.