Top 21 Regulatory affairs manager Jobs in Wilmington, De

Senior Manager, Regulatory Affairs CMC
Incyte Corporation —Wilmington, DE
- Travel
- Senior level
9d
Senior Manager, Regulatory Affairs
West Pharmaceutical Services —Exton, PA
- Hybrid work
- Background check
- 5 years
- Doctor of Philosophy
Senior IIS and Grants Manager - Hybrid
Ledgent Technology —King of Prussia, PA
- $53.57 - $74.29 an hour
- Full-time
- 8 years
- Presentation skills
- Bachelor's degree
Quick Apply
North American Regulatory Affairs Specialist
International Flavors & Fragrances —Wilmington, DE
- Full-time
- Hybrid work
- Mid-level
- 3 years
- Bachelor's degree
Senior Manager, Regulatory Operations
Incyte Corporation —Wilmington, DE
- Writing skills
- Office
- Bachelor's degree
Manager, GLP Compliance– Remote- Philadelphia, PA
Cabaletta Bio —Philadelphia, PA
- Remote
- Bachelor's degree
- Organizational skills
- 1 year
- Health insurance
- Paid time off
Specialist 3 - Regulatory Affairs
Katalyst Healthcares & Life Sciences —West Chester, PA
- Contract
- Hybrid work
- Bachelor of Science
- Writing skills
- Engineering
Quick Apply
Mgr, Advocacy, Product Stewardship & Regulatory Affairs
AGC Chemical Americas —Exton, PA
- $125,000 - $145,000 a year
- Full-time
- OSHA
- 8 years
- Bachelor's degree
Quick Apply
Manager, Regional Regulatory Lead - LCM
CSL Behring —King of Prussia, PA
- $129,000 - $153,000 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Doctor of Philosophy
10d
Regulatory Filing Compliance Analyst
Penn Lumbermens Mut Ins Co —Philadelphia, PA
- Microsoft Word
- Writing skills
- Mid-level
Regulatory Compliance Specialist (Food Labeling)
Chelten House Products, Inc. —Swedesboro, NJ
- $80,000 - $85,000 a year
- Mid-level
- Databases
- Project management
- Health insurance
- Dental insurance
Quick Apply
12d
Pharmaceutical State Licensing Project Manager
LighthouseAI, a Pharma Solutions Company —Philadelphia, PA
- $0 a year
- Full-time
- Remote
- Microsoft Word
- Microsoft Outlook
- Writing skills
- Disability insurance
- Health insurance
Quick Apply
Regulatory Product Analyst
Penn Lumbermens Mut Ins Co —Philadelphia, PA
- Writing skills
- Research
- Mid-level
Product Stewardship and Regulatory Affairs Sp
AGC Chemical Americas —Exton, PA
- $88,000 - $96,000 a year
- Full-time
- ERP systems
- Mid-level
- Office
Quick Apply
Director, Oncology Translational Medicine Project Manager
GlaxoSmithKline —Upper Providence, PA
- Full-time
- 8 years
- Bachelor's degree
- Organizational skills
Specialist, NWM Sales Quality
NRG —Philadelphia, PA
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quick Apply
Global Business Practices Compliance Officer
Teleflex —Wayne, PA
- Up to 50% travel
- Customer service
- Writing skills
Project Lead - RUA92307
IQVIA —Philadelphia, PA
- $200,000 - $225,000 a year
- Full-time
- Nursing
- Driver's License
- Travel
1d
Vice President, Program Management
Uniquity Bio Inc. —Malvern, PA
- Full-time
- 11+ years
- Office
- Bachelor's degree
Quick Apply
Commercial Launch Project Manager (CONTRACT)
Summit Therapeutics —Philadelphia, PA
- $74 - $80 an hour
- Contract
- 3 years
- Analysis skills
- Bachelor's degree
Quick Apply
3d

I want to receive the latest job alert for regulatory affairs manager in wilmington, de

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs manager jobs near wilmington, de

Compliance Officer jobs in Wayne, PA

Product Analyst jobs in Philadelphia, PA

Regulatory Affairs Specialist jobs in Exton, PA

Senior Operations Manager jobs in Remote

Compliance Manager jobs in Philadelphia, PA

Regulatory Affairs Specialist jobs in Wilmington, DE

Commercial Project Manager jobs in Philadelphia, PA

Compliance Officer jobs in Philadelphia, PA

Quality Specialist jobs in Philadelphia, PA

Regulatory Specialist jobs in Chapel Hill, NC

Dietary Supplement Regulatory jobs in Remote

Regulatory Specialist jobs in Everett, WA

Regulatory Affairs jobs in Salt Lake City, UT

Regulatory Specialist jobs in Florida

Food Regulatory Affairs jobs in Remote

Regulatory Specialist jobs in Michigan

Compliance Officer jobs in Mcallen, TX

Compliance Officer jobs in Las Vegas, NV

Compliance Officer jobs in San Francisco, CA

Chief Executive Officer Ceo jobs in Michigan

Senior Manager, Regulatory Affairs CMC

Incyte Corporation -
Wilmington, DE

Apply Now

Job Details

9 days ago

Qualifications

Document control experience within pharmaceutical industry
Clinical development
Drug regulation
Records management
Chemistry, manufacturing & controls

Full Job Description

Overview:

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary function)

This role will primarily be responsible for managing regulatory CMC submissions and strategy for Incyte development and marketed products, including both small molecules and biologics, from early development through late-stage (phase 3, registration and post-approval).

Essential Functions of the Job (Key responsibilities)

Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
Maintains current knowledge of relevant US and international guidance's, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
Liaises with FDA and other global health authorities as needed (e.g. telephone contacts, submissions). Leads or participates in regulatory CMC related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives.
Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent, and complete. Provides thorough review of the CMC data packages from team representatives to support clinical trial and marketing applications. Collaborates with CMC experts to provide timely responses to CMC regulatory questions from global health authorities. Oversees post-approval global product activities such as change control, product feedback, marketing application supplements, and variations.
Leads or participates in meetings with internal and external stakeholders/business partners or teams for clinical development programs, in order to communicate regulatory CMC guidance and strategies.
Leads or manages regulatory CMC strategy and submission aspects for both small and large molecule development programs.
Ensures compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.

Qualifications (Minimal acceptable level of education, work experience, and competency)

In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.
Minimum of relevant experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs desirable.
Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems.
A degree in a relevant field is required. Advanced degrees in scientific, Regulatory Affairs, or related pharmaceutical fields are desirable, but equivalent experience will also be considered.
Willingness to travel domestically up to 10% with reasonable accommodations provided for individuals with disabilities.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact [email protected] if you have any questions or concerns or would like to exercise your rights.

Apply Now

Refine Your Search

regulatory affairs manager jobs in wilmington, de

Senior Manager, Regulatory Affairs CMC

Senior Manager, Regulatory Affairs

Senior IIS and Grants Manager - Hybrid

North American Regulatory Affairs Specialist

Senior Manager, Regulatory Operations

Manager, GLP Compliance– Remote- Philadelphia, PA

Specialist 3 - Regulatory Affairs

Mgr, Advocacy, Product Stewardship & Regulatory Affairs

Manager, Regional Regulatory Lead - LCM

Regulatory Filing Compliance Analyst

Regulatory Compliance Specialist (Food Labeling)

Pharmaceutical State Licensing Project Manager

Regulatory Product Analyst

Product Stewardship and Regulatory Affairs Sp

Director, Oncology Translational Medicine Project Manager

Specialist, NWM Sales Quality

Global Business Practices Compliance Officer

Project Lead - RUA92307

Vice President, Program Management

Commercial Launch Project Manager (CONTRACT)

I want to receive the latest job alert for regulatory affairs manager in wilmington, de

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected