Regulatory affairs Jobs in Chicago, IL
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Regulatory affairs • chicago il
Last updated: 8 hours ago
Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, bi...Show moreLast updated: 30+ days ago
A company is looking for a Regulatory & External Affairs Analyst.Key Responsibilities Prepare, review, and submit regulatory reports to federal and state agencies Support the preparation and sub...Show moreLast updated: 30+ days ago
Global Scientific & Regulatory Affairs Manager, Sustainability Regulatory Compliance Program.The Global Scientific & Regulatory Affairs Manager, Sustainability Regulatory Compliance Program, leads ...Show moreLast updated: 22 days ago
Associate Director of CMC Regulatory Affairs.CMC regulatory development plans and for successful execution against those plans.
The Associate Director must be articulate and influence decision-makin...Show moreLast updated: 21 days ago
Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration.Partic...Show moreLast updated: 30+ days ago
The R&D Regulatory Affairs Finance team supports the leadership in strategic planning and execution of both current and long-term goals around resource and budget management.This position is re...Show moreLast updated: 22 days ago
Director, Regulatory Affairs Americas.At Barry Callebaut, we are on a journey to transform the cocoa and chocolate industry.
As the world’s leading manufacturer of high-quality chocolate and cocoa p...Show moreLast updated: 30+ days ago
Responsibilities : Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products r...Show moreLast updated: 30+ days ago
About Adtalem Global Education.Adtalem Global Education is a national leader in post-secondary education and leading provider of professional talent to the healthcare industry.Adtalem educates and ...Show moreLast updated: 30+ days ago
Director, Regulatory Affairs Americas.At Barry Callebaut, we are on a journey to transform the cocoa and chocolate industry.
As the world's leading manufacturer of high-quality chocolate and cocoa p...Show moreLast updated: 30+ days ago
Global Regulatory Affairs Manager.Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and...Show moreLast updated: 29 days ago
Senior / Consultant, Regulatory Labeling.When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health.From clinical trials to ...Show moreLast updated: 18 days ago
Job Description Crowe LLP is seeking an Assistant General Counsel for Litigation and Regulatory Affairs.The Assistant General Counsel will manage the firm's responses to all litigation, regulatory...Show moreLast updated: 18 days ago
Food Safety Quality And Regulatory Affairs Manager.Reporting to the Manager Food Safety Quality & Regulatory Affairs, you will independently implement programs within given functional area of the f...Show moreLast updated: 30+ days ago
Top biotechnology (BioTech) company developing innovative treatments.The Company is seeking a Head of Regulatory Affairs to provide strategic leadership and oversight of all regulatory activities r...Show moreLast updated: 8 hours ago
Director, Regulatory Affairs Americas.Barry Callebaut is a global organization poised for growth; a company which has embraced the vision to delight its customers, while out-performing its competit...Show moreLast updated: 28 days ago
Regulatory Compliance Coordinator.The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD).
The BSD is the largest of four Div...Show moreLast updated: 29 days ago
RWE Clean Energy, LLC To start as soon as possible, full time, permanent Legal / Compliance The Assistant General Counsel will provide legal support to the U.
United States, as determined by managem...Show moreLast updated: 1 day ago
Position Title : Assistant General Counsel Chicago, IL – 222 West Adams Street, Suite 2150, Chicago, IL 60606, USA What You'll Do Procurement Responsibilities : Drafts, reviews and negotiates a varie...Show moreLast updated: 1 day ago
- Promoted
Regulatory Affairs Manager
Meitheal PharmaceuticalsChicago, IL, United StatesFull-time
Regulatory Affairs Analyst
VirtualVocationsChicago, Illinois, United StatesFull-time
- Promoted
Global Scientific & Regulatory Affairs Manager, Sustainability Regulatory Compliance Program
MarsChicago, IL, USFull-time
Associate Director, Global CMC Regulatory Affairs
The Steely GroupHybrid, Chicago, IL, USFull-time
Quick Apply
Regulatory Affairs Consultant
Katalyst HealthCares & Life SciencesChicago, ILFull-time
- Promoted
R&D Finance Manager, Regulatory Affairs
AbbVieNorth Chicago, Illinois, USAFull-time
Director, Regulatory Affairs Americas
Barry CallebautChicago, US,Full-time
- Promoted
Regulatory Affairs Consultant
Katalyst Healthcares & Life SciencesChicago, IL, USFull-time
Senior Director Regulatory Affairs
Adtalem Global EducationChicago, IL, USFull-time
- Promoted
Director, Regulatory Affairs Americas
Barry Callebaut AGChicago, IL, USFull-time
- Promoted
Senior Manager, Global Regulatory Affairs
Otsuka PharmaceuticalChicago, IL, USFull-time
- Promoted
Senior Regulatory Affairs Consultant - Labeling (European Expertise)
ParexelChicago, IL, USFull-time
- Promoted
Litigation and Regulatory Affairs Assistant General Counsel
CroweChicago, IL, USFull-time
- Promoted
Sr Food Safety Quality & Regulatory Affairs Specialist
Conagra BrandsChicago, IL, USFull-time
- Promoted
- New!
Head of Regulatory Affairs (Chicago)
ConfidentialChicago, IL, United StatesFull-time
- Promoted
Director, Regulatory Affairs Americas
Chicago StaffingChicago, IL, USFull-time
- Promoted
Regulatory Affairs Manager
University of ChicagoChicago, IL, USFull-time
- Promoted
Assistant General Counsel, Regulatory Affairs
RWE GruppeChicago, Illinois, United StatesFull-time +1
- Promoted
Assistant General Counsel, Regulatory Affairs
EquiTrust Life Insurance CompanyChicago, Illinois, United StatesFull-time
The average salary range is between $ 65,000 and $ 155,050 year , with the average salary hovering around $ 102,072 year .
- vascular surgeon (from $ 325,000 to $ 525,000 year)
- private banker (from $ 54,250 to $ 500,000 year)
- orthopedic surgeon (from $ 43,750 to $ 437,500 year)
- dermatologist (from $ 50,000 to $ 437,500 year)
- interventional radiologist (from $ 108,144 to $ 431,853 year)
- diagnostic radiologist (from $ 24,000 to $ 418,650 year)
- emergency medicine physician (from $ 49,482 to $ 395,500 year)
- surgeon (from $ 40,000 to $ 385,000 year)
- human resource consultant (from $ 92,500 to $ 375,000 year)
- human resources consultant (from $ 92,500 to $ 375,000 year)
- Boston, MA (from $ 125,771 to $ 200,600 year)
- Cambridge, MA (from $ 113,100 to $ 200,200 year)
- Atlanta, GA (from $ 87,750 to $ 195,950 year)
- San Francisco, CA (from $ 103,208 to $ 195,773 year)
- San Jose, CA (from $ 104,003 to $ 194,780 year)
- San Diego, CA (from $ 104,546 to $ 193,259 year)
- New York, NY (from $ 90,142 to $ 189,903 year)
- Seattle, WA (from $ 95,000 to $ 185,000 year)
- Pittsburgh, PA (from $ 49,920 to $ 177,310 year)
- Houston, TX (from $ 69,257 to $ 170,000 year)
The average salary range is between $ 74,006 and $ 170,765 year , with the average salary hovering around $ 105,135 year .
Regulatory Affairs Manager
Meitheal PharmaceuticalsChicago, IL, United States30+ days ago
Job type
- Full-time
Job descriptionThe primary responsibility will include authoring, reviewing and preparing high quality ANDA, NDA, BLA, IND and DMF submissions. Prepare, review and submit responses to FDA's CRLs, DRLs and Information Requests within predetermined and negotiated deadlines. Review and submit post-approval supplements, safety update reports to INDs, NDAs, ANDAs and BLAs. Participate in development and commercial team meetings representing RA CMC. Review and approve change controls from global manufacturing partners Experienced with FDA's eCTD requirements for Modules 1-5. Work in a collaborative environment with cross-functional teams, not limited to Labeling, R&D, Manufacturing, Medical Affairs, Operations, Marketing and Quality. Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor. Maintains current knowledge of regulations. Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements. Support Biosimilar BLA / PAS / CBE submissions, as assigned. Planning and Organizing Communication Strategic Thinking Teamwork Problem Solving Quality Judgement Dependability Assimilate to changing environments. Ability to prioritize and multitask. Organized and detailed orientated. Have a sense of urgency to meet all required deadlines Bachelor's degree in life sciences from a 4-year college or university with 5 or more years of direct experience in Regulatory Affairs within bio / pharmaceutical companies, with focus in CMC. Candidates with additional prior experience in R&D or Manufacturing will be a plus. Excellent attention to details, technical writing, organizational and communication skills. Ability to prioritize and handle multiple projects concurrently. Familiar with 21 CFR, FDA and ICH.
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Job Type
Full-time
Description
About Us :
Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.
Position Summary :
The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC.
The pay range for this position is : $85,000 - $115,000.
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
Why Work with Us?
- Hybrid Work Schedule : Enjoy the flexibility to work remotely three days a week.
- Casual Dress Code : Embrace a relaxed and comfortable dress code that allows you to express your personal style.
- Collaborative Culture : Join a team that values open communication, teamwork, and the exchange of ideas.
- Professional Growth : We offer ample opportunities for professional development and career advancement.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Competencies
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Education and / or Experience :
Equal Opportunity Employer :
Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
Salary Description
$85,000 to $115,000