CMC Regulatory Affairs Associate II Hybrid Strategy & Submissions
Orion Group
Orion Group in North Chicago, IL, is seeking a Regulatory Affairs Associate II to support CMC regulatory strategy and lifecycle management for marketed and development-stage products. You will work with internal and external partners to prepare regulatory strategies and submissions. The role involves drafting CMC filing dossiers, managing submissions (INDs, CTAs, renewals, annual reports), and ensuring compliant documentation within a matrix environment; hybrid work is preferred. #J-18808-Ljbffr Orion Group
- Regulatory Affairs Associate II - CMC Regulatory Strategy and Lifecycle Management Location: Hybrid Preferred - North Chicago, Illinois Length of Assignment: 2 years Pay Rate:... ...helps prepare regulatory strategies and submissions that support timely approvals and continued...SuggestedWork at officeWorldwide
$35 per hour
...Global Pharma Leader in North Chicago, IL! This exciting 2-year hybrid contract role as a Regulatory Affairs Associate II offers the opportunity to drive CMC regulatory strategies and prepare high-impact submission dossiers for globally life-changing products. location:...SuggestedHourly payContract workTemporary workWork experience placement- Spectraforce Technologies is seeking a Regulatory Affairs Associate II in North Chicago, IL, hybrid work arrangement. The role... ...teams to develop and manage CMC regulatory strategies that enable first-pass... ...preparing regulatory submissions, evaluating changes for regulatory...Suggested
- ...Position Title: Regulatory Affairs Associate II Work Location: North... ...Work Arrangement: Hybrid Position Summary:... ...Senior Associate, RA CMC works with internal... ...Prepares CMC regulatory strategies that enable first... ...strategy for regulatory submissions, including INDs/CTAs...Suggested
- ...Description The Senior Associate, RA CMC is responsible... ...preparation of submission documents. The... ...in support of regulatory filings. Responsibilities... ...plans, bundling strategies, and project... ...role works a hybrid work schedule (3... ...years in regulatory affairs or 1-2 years in...SuggestedFull timeTemporary workWork at officeLocal areaRemote work
- ...Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development... ...(Global Regulatory Lead (GRL), Associate Director, or Director), in the... ...and review of regulatory submissions consistent within US and Canada...Local area
- ...Instagram, X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact, moderately... ...less experienced staff. ~ This position will work a hybrid work schedule, 3 days in office & 2 days remote, from...Temporary workWork at officeLocal areaRemote work
$39 per hour
...summary: Advance your career as a Regulatory Affairs Associate II with a Top-Tier Global Pharma Leader in North Chicago, IL. This hybrid role offers an exciting opportunity to... ...patients while managing key regulatory submissions and filings. location: North Chicago...Hourly payContract workTemporary workWork experience placement- AbbVie North Chicago, IL is seeking a Senior Associate Regulatory Affairs Submission Management for a hybrid role. The position involves managing medium to high impact regulatory submission projects, coordinating cross-functional teams, and guiding publishing timelines...
- AbbVie in North Chicago, IL is seeking a Senior Associate, Regulatory Affairs Submission Management to drive medium-to-high impact regulatory submissions. You will coordinate cross-functional teams, manage timelines, and liaise with publishing vendors to ensure compliant...
$29 - $32.29 per hour
...Are you a detail-oriented regulatory professional with strong technical... ...in North Chicago, IL, on a hybrid schedule. In this high-visibility... ...Manufacturing, and Controls (CMC) dossier content to ensure... ...CMC Module 3 content and submission dossiers for marketed product...Hourly payContract workTemporary workWork experience placement- ...Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible for the... ...supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements...
- ...manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This... ...in support of regulatory filings. Manage, compile... ...2 years in regulatory affairs, R&D, or Manufacturing... ...adjusting priorities and strategies as necessary....Full timeShift work
- ...Description The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product... ...CMC regulatory strategies that enable first pass... ...strategy for regulatory submissions, including INDs/CTAs and... ...position will work a hybrid work schedule (3 days...Full timeWork at officeLocal area
- ..., X and YouTube. Job Description The Manager, Regulatory Affairs Submission Management , manages high impact, complex submission... ...establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings...Full timeLocal area
- ...Responsibilities: The Regulatory Affairs Level III (Senior Specialist... ...devices (including Class I and II devices, software as a... ...standards Develop regulatory strategies to achieve market clearance... ...510(k) and/or De Novo submissions for FDA Technical documentation...
- ...Recruiter - Unicon Pharma Inc Regulatory Affairs Specialist Provide... ...and global medical device submissions, including FDA and EU requirements... ...of global regulatory strategies and ensure compliance for submissions... ...). Seniority level: Associate Employment type: Contract...Contract work
- Hybrid Senior Manager, Regulatory Affairs About the job Hybrid Senior Manager, Regulatory Affairs Introduction... ...role involves leading the regulatory strategy for new and modified medical... ...communicate regulatory development, submission strategies, and interface with relevant...Work at officeWorldwide
- ...structuring goals-based investment plans. The role involves client relationship growth, asset allocation decisions, annual reviews, and coordination with the Investment Committee to ensure compliant, tailored financial strategies. #J-18808-Ljbffr First Financial Bank
- Planet Pharma is seeking a Regulatory Information Management support professional in Illinois. The role focuses on regional regulatory submissions, system-based data stewardship, and ensuring alignment with central data standards. Fresh graduates with relevant life sciences...
- ...Remote Responsibilities: Support regional Regulatory Information Management (RIM) activities... ...regional teams to ensure regulatory submissions and correspondence are accurately documented... ...: Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related...Remote work
- ...engineers, and management heads to identify process improvement opportunities, propose system modifications, and devise data governance strategies. Preparing final analysis reports for the stakeholders to understand the data-analysis steps, enabling them to make important...Work experience placementLocal area
- ...Regulatory Affairs AssociateLocation: Lake Forest, ILDuration: 12 MonthsPay Rate: $33-$35 on W2 per hour.Position... ...regulatory support and expertise associated with global and US electronic publishing and submission of medical devices, including understanding the...Hourly pay
- ...Regulatory Affairs Specialist Responsible for filing necessary applications and handling all government interactions pertaining to the... ...medical devices; proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge...
$37 per hour
...Job Title: Financial Analyst II Location: North Chicago, IL 60064 (Hybrid - 3 days onsite & 2 days remote) Duration: 06+ months (possible extension or contract to hire) Shift Timing: 1st shift, Monday - Friday, Standard business hours Salary: $37...Hourly payContract workLocal areaRemote workMonday to FridayFlexible hoursShift workDay shift- Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies... ...and taking leadership roles in professional associations, industry, and trade groups as appropriate...Worldwide
- AbbVie in North Chicago, IL is seeking a Director Regulatory Affairs Global Regulatory Lead to drive global strategies for development and lifecycle management. You... ...to ensure regulatory readiness and compliant submissions. The role requires 7+ years in regulatory affairs...
$200k - $230k
...SUMMARY: The Director, US Regulatory Affairs Strategy, oversees the... ...team on a dotted-line basis (CMC, Regulatory Operations, US... ...experience with face to face, hybrid, and/or virtual FDA interactions... ...including participation in submissions to ex-US authorities TRAVEL...Flexible hours- ...distributor in North America and Japan, is seeking a Manager, Customer Strategy. This role uses customer data to provide detailed insights and... ...growth for both new and existing customers. This is a hybrid position with onsite requirements. The ideal candidate has 5+ years...
- ...Description The Senior Manager, Regulatory Strategic Planning, is... ...within and across the Regulatory Affairs organization. The individual... ...of AbbVie’s regulatory strategies. The Senior Manager will be developing... .... This role will work a hybrid work schedule (3 days in...Full timeWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Affairs Associate II Hybrid Strategy & Submissions. Be the first to apply!
- regulatory specialist North Chicago, IL
- compliance officer North Chicago, IL
- coding compliance specialist North Chicago, IL
- aml compliance analyst North Chicago, IL
- compliance analyst North Chicago, IL
- medicare compliance specialist North Chicago, IL
- regulatory officer North Chicago, IL
- research compliance officer North Chicago, IL
- regulatory analyst North Chicago, IL
- regulatory compliance associate North Chicago, IL


