Top 69 Regulatory affairs Jobs in Durham Nc

Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
Chiesi Farmaceutici —Cary, NC
- $121,000 - $182,000 a year
- Overtime
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Health insurance
Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Raleigh, NC
- Part-time
- Remote
- Senior level
- Leadership
- 10 years
US Regulatory Manager
UPL ltd —Cary, NC
- Full-time
- 5 years
- Mid-level
- Presentation skills
Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)
BASF —Research Triangle Park, NC
- Full-time
- Hybrid work
- Bachelor of Science
- 11+ years
- Bachelor's degree
- Adoption assistance
- Parental leave
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
QC LCM / Stability Lead
Kelly Services —Raleigh, NC
- $98,000 - $138,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Quick Apply
14d
Experienced Clinical Research Associate - Sponsor Dedicated
Syneos - Clinical and Corporate - Prod —North Carolina
- Full-time
- Mid-level
- Bachelor's degree
- Travel
- Employee stock purchase plan
- Health insurance
Regulatory Affairs Manager - CMC & Labeling
United Therapeutics —Research Triangle Park, NC
- Full-time
- Hybrid work
- Office
- Master's degree
- Project management
- Paid parental leave
- Employee stock purchase plan
Regulatory Affairs Manager
bioventus —Durham, NC
- Full-time
- 5 years
- Senior level
- Communication skills
Participant Recruitment Analyst
Wake Research —Raleigh, NC
- Full-time
- Remote
- LVN
- HIPAA
- Mid-level
- Disability insurance
- Health insurance
Quick Apply
7d
Senior Manager, Regulatory Affairs
Azurity Pharmaceuticals - US —Raleigh, NC
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- Microsoft Office
- Fuel card
- Health insurance
10d
Clinical Operations Specialist
ICON Plc —Raleigh, NC
- Full-time
- Mid-level
- Bachelor's degree
- Continuous improvement
- Disability insurance
- Health insurance
6d
Senior Associate, Regulatory CMC
HUMACYTE GLOBAL INC —Durham, NC
- Full-time
- Remote
- Bachelor of Science
- Writing skills
- Bachelor's degree
- Paid parental leave
- Paid holidays
Quick Apply
Senior Nonclinical Regulatory Affairs Scientist
RTI International —Raleigh, NC
- $125,000 - $220,000 a year
- Doctor of Philosophy
- Organizational skills
- Fair chance
- Paid parental leave
- Disability insurance
Sr Manager, Regulatory Labeling and Ad Promo
ICON Plc —Raleigh, NC
- Full-time
- Remote
- Bachelor's degree
- Senior level
- Commercial
- Disability insurance
- Health insurance
14d
Assoc. Director, Regulatory Affairs Advertising and Promotion
Definium Therapeutics —Durham, NC
- $160,000 - $190,000 a year
- Remote
- Psychiatry
- Bachelor of Science
- 8 years
- Health insurance
- Dental insurance
13d
Associate Director, Development Project Management
Definium Therapeutics —Durham, NC
- $150,000 - $195,000 a year
- Remote
- Psychiatry
- 8 years
- Bachelor's degree
- Health insurance
- Dental insurance
QC INVESTIGATOR
Aurobindo Pharma USA, Inc. —Durham, NC
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Health savings account
- AD&D insurance
Sr Clinical Research Associate
Veranex, Inc. —Raleigh, NC
- $98,400 - $140,690 a year
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
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

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Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Chiesi Farmaceutici -
Cary, NC

Apply Now

Job Details

Permanent
$121,000 - $182,000 a year

Benefits

Health insurance

Qualifications

Content creation for technical audiences
Document control experience within pharmaceutical industry
Drug regulation
TrackWise
Quality management
ICH guidelines
Bachelor's degree
Technology transfer (scale-up process)
Chemistry, manufacturing & controls
Biomedical regulatory compliance
Technical writing experience within technology
Information management

Full Job Description

Date: Aug 20, 2026

Department: GRD Regulatory Affairs

Job Type: Direct Employee

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type: Permanent

Location:

Cary, NC, US

About Us

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.

Who we are looking for

This is what you will do

Currently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products.

You’ll be responsible for:

Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategy
Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervision
Act as the GRDRA CMC representative at core team level with a global role, where required
Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorization applications, investigational applications and variations/supplements, worldwide
Advise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier
Review and assess change control requests pertaining to CMC aspects of GRD product(s)
In alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life cycle and development
Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.
Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.
In agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier
Support the development of processes and to the preparation of Standard Operating Procedures where required.
Support due diligence activities on CMC regulatory documents, where required
Represent GRDRA during GMP inspections by regulatory agencies, where required
Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.

You will need to have

Minimum of a bachelor’s degree in a Scientific or Technical Discipline
5 + years of Regulatory CMC experience
Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements
Sound knowledge of manufacturing technical transfer and comparability regulatory requirements
Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.
Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system
Strong attention to detail. Ability to multi-task, stay organized and prioritize.
Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.
Ability to work independently and in a group setting and thrive in a fast-paced environment

We would prefer for you to have

Advanced Degree in a Scientific or Technical Discipline

Location

Hybrid role based in our Cary, NC office. #LI-Hybrid

Compensation

The annual base pay for this position ranges from $121,000 to $182,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

Apply Now

Refine Your Search

regulatory affairs jobs in durham nc

Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Regulatory Affairs Consultant, In Silico Modeling

US Regulatory Manager

Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)

Sr. Director, Strategic Regulatory Affairs and UDI

QC LCM / Stability Lead

Experienced Clinical Research Associate - Sponsor Dedicated

Regulatory Affairs Manager - CMC & Labeling

Regulatory Affairs Manager

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Senior Manager, Regulatory Affairs

Clinical Operations Specialist

Senior Associate, Regulatory CMC

Senior Nonclinical Regulatory Affairs Scientist

Sr Manager, Regulatory Labeling and Ad Promo

Assoc. Director, Regulatory Affairs Advertising and Promotion

Associate Director, Development Project Management

QC INVESTIGATOR

Sr Clinical Research Associate

Director of Regulatory - Biological & Traditional Fertilizers

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