Top 300 Regulatory affairs Jobs in Durham Nc

QC Chemistry Lead
Guerbet —Raleigh, NC
- Full-time
- 5 years
- Computer literacy
- Master's degree
13d
CRA - Future Roles (US)
Syneos - Clinical and Corporate - Prod —North Carolina
- Full-time
- Mid-level
- Bachelor's degree
- Travel
- Employee stock purchase plan
- Health insurance
Regulatory Affairs Associate (entry level)
Grifols —Durham, NC
- Full-time
- Research
- Office
- Associate's degree
Regulatory Affairs Manager
bioventus —Durham, NC
- Full-time
- 5 years
- Senior level
- Communication skills
Sr. Regulatory Affairs Specialist
bioventus —Durham, NC
- Full-time
- Research
- Organizational skills
- Senior level
Regulatory Affairs Director
IQVIA —Durham, NC
- $128,800 - $358,800 a year
- Full-time
- Management
- 8 years
- Analysis skills
4d
Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics
United Therapeutics —Research Triangle Park, NC
- Full-time
- Hybrid work
- Office
- Microsoft Office
- Bachelor's degree
- Paid parental leave
- Employee stock purchase plan
Associate Director, Regulatory Affairs (CMC)
Kriya Therapeutics —Research Triangle Park, NC
- Full-time
- Office
- 8 years
- Travel
- Paid parental leave
- Paid holidays
Quick Apply
Sr. Director, Strategic Regulatory Affairs and UDI
Teleflex —Morrisville, NC
- $203,000 - $253,000 a year
- 11+ years
- Office
- Analysis skills
- Disability insurance
- Health insurance
12d
Director (Senior Director), Regulatory Affairs
SHATTUCK LABS, INC. —Durham, NC
- $190,000 - $260,000 a year
- Full-time
- Microsoft Word
- Office
- 8 years
- Health insurance
- 401(k)
Quick Apply
Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Raleigh, NC
- Part-time
- Senior level
- Leadership
- 10 years
Global Regulatory CMC Scientist (Raleigh)
UCB —Raleigh, NC
- Office
- Master's degree
- Bachelor's degree
Associate Corporate Compliance Director – Commercial & Medical Affairs
United Therapeutics —Research Triangle Park, NC
- $145,500 - $205,000 a year
- Full-time
- Microsoft Excel
- Finance
- Analysis skills
- Paid parental leave
- Employee stock purchase plan
Director of Regulatory - Biological & Traditional Fertilizers
The Mosaic Company —Durham, NC
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Master's degree
- Paid parental leave
- Paid holidays
12d
Executive Director, Clinical Development & Medical Affairs
HUMACYTE GLOBAL INC —Durham, NC
- Medicine
- 5 years
- Office
- Paid parental leave
- Paid holidays
Quick Apply
11d
Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Atsena —Durham, NC
- $160,000 - $220,000 a year
- Full-time
- Medicine
- 7 years
- Management
Quick Apply
4d
Senior Manager, Regulatory Affairs (Ad Promo)
ICON Plc —Raleigh, NC
- Full-time
- 7 years
- Supervising experience
- Bachelor's degree
- Disability insurance
- Health insurance
Sr. Medical Writer (Regulatory)
サイネオス・ヘルス —Morrisville, NC
- $80,600 - $145,000 a year
- Travel
- Mentoring
- Senior level
- Employee stock purchase plan
- Health insurance
Associate Director, Medical Marketing
Definium Therapeutics —Durham, NC
- $170,000 - $197,911 a year
- Remote
- Psychiatry
- Marketing
- Bachelor's degree
- Health insurance
- Dental insurance
US State Regulatory Manager
UPL ltd —Cary, NC
- Full-time
- 5 years
- Bachelor's degree
- Continuous improvement

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QC Chemistry Lead

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time
13 days ago

Qualifications

Computer operation
Drug regulation
Chemist team management
Data integrity and documentation
Pharmaceutical company experience
Pharmaceutical analysis
Chemical testing

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The QC Chemistry Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

At the Guerbet Raleigh Imaging manufacturing facility, the Quality Control Lead is responsible for overseeing analytical testing and quality assurance processes within the chemistry lab. This role ensures compliance with cGMP (Current Good Manufacturing Practices), ICH guidelines, and regulatory standards while leading a team of chemists to maintain the integrity and accuracy of pharmaceutical products.

YOUR ROLE

Lead, support, and mentor a team of QC chemists, ensuring adherence to laboratory protocols and regulatory requirements.
Oversee the testing of raw materials, in-process samples, finished drug substances, and stability studies to ensure product quality.
Implement and maintain quality control procedures to ensure compliance with FDA, EMA, and other regulatory agencies.
Conduct investigations into out-of-specification (OOS) results and deviations (EXC), implementing corrective and preventive actions (CAPA).
Ensure proper documentation and data integrity in accordance with Good Laboratory Practices (GLP).
Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to support product development and release.
Maintain and troubleshoot laboratory instruments such as HPLC, FTIR, UV-Vis Spectrophotometers, and other analytical equipment.
Lead audits and inspections, ensuring readiness for regulatory reviews.
Provide training and guidance to QC staff on analytical techniques and compliance standards.
Ensure testing is performed in compliance with USP/EP/JP and internal specifications, SOPs, and cGMP standards.
Participate in method transfers, validations, and verifications.
Maintain lab readiness for regulatory inspections and internal audits.
Train, mentor, and evaluate lab analysts; ensure proper documentation and lab safety practices.
Support continuous improvement projects, including implementation of new equipment, methods, or automation tools
Performs other duties as assigned by management

YOUR BACKGROUND

Education: Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related scientific discipline.
5+ years of pharmaceutical QC laboratory experience with a strong background in analytical chemistry.
1–3 years in a leadership or senior analyst role preferred.
Proficiency with HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry.
Familiarity with LIMS, CDS (e.g., Empower), and laboratory instrumentation qualification.
Strong understanding of cGMP, FDA, ICH, and USP guidelines.
Knowledge of industry regulations and best practices for data integrity.
Effective communication and problem-solving skills.
Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements
Demonstrated auditing and corrective action proficiency.
Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.

Cognitive Requirements:

Ability to read and understand military time.
Experience in data quality control, auditing, or regulatory compliance.
Strong analytical skills and attention to detail.
Excellent leadership and team management abilities.
Proficiency in data management tools and software.
Excellent problem solving and decision-making skills.
Ability to manage and drive change
Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.
Computer skills
Knowledge of document management/quality systems
Ability to manage projects and processes with multiple functional groups without direct reporting authority
Strong communication and interpersonal skills
Getting work done through others that are not direct reports
Operates with minimal direction, self-starter
Building relationships with other departments

Apply Now

Refine Your Search

regulatory affairs jobs in durham nc

QC Chemistry Lead

CRA - Future Roles (US)

Regulatory Affairs Associate (entry level)

Regulatory Affairs Manager

Sr. Regulatory Affairs Specialist

Regulatory Affairs Director

Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics

Associate Director, Regulatory Affairs (CMC)

Sr. Director, Strategic Regulatory Affairs and UDI

Director (Senior Director), Regulatory Affairs

Regulatory Affairs Consultant, In Silico Modeling

Global Regulatory CMC Scientist (Raleigh)

Associate Corporate Compliance Director – Commercial & Medical Affairs

Director of Regulatory - Biological & Traditional Fertilizers

Executive Director, Clinical Development & Medical Affairs

Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)

Senior Manager, Regulatory Affairs (Ad Promo)

Sr. Medical Writer (Regulatory)

Associate Director, Medical Marketing

US State Regulatory Manager

I want to receive the latest job alert for regulatory affairs in durham nc

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