Senior Manager, Regulatory Affairs CMC

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

Job SummaryAbbVie is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the successful execution of post-approval change objectives for marketed products.Key ResponsibilitiesProject Management: Independently manage, compile, and author CMC sections...

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...

About the RoleMeitheal Pharmaceuticals Inc is seeking a highly experienced Senior Director of Regulatory Affairs, Specialty Pharmaceuticals to lead our regulatory strategy for specialty pharma products. This is a critical role that will play a key part in the growth and transformation of our regulatory team.Key ResponsibilitiesRegulatory Strategy: Provide...

DescriptionCompany Overview:Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to...

Position Overview: This role is 100% remote and focuses on the management of Chemistry, Manufacturing, and Control (CMC) regulatory activities.Key Responsibilities: Oversee project management for variations of marketed products, including the preparation and compilation of CMC documentation to ensure timely submissions.Utilize electronic document management...

Position Overview: We are seeking a CMC Regulatory Specialist [Project Manager I] to oversee critical projects within our organization. This role is fully remote and focuses on managing the chemistry, manufacturing, and control (CMC) aspects of product variations.Key Responsibilities:Lead project management efforts for marketed product variations, including...

Job SummaryThe Senior Manager, Regulatory Strategic Planning, is a key member of the AbbVie team responsible for delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization.Key ResponsibilitiesProject Management Leadership: Provides project management leadership in...

Position Overview:Katalyst HealthCares & Life Sciences Inc. is seeking motivated entry-level professionals for various roles in contract research related to clinical trials involving pharmaceuticals, biologics, and medical devices.As an E-Verified organization, we welcome candidates on OPT and CPT, and we offer H1B (both CAP and CAP exempt) and Green Card...

Position Overview:Katalyst HealthCares & Life Sciences Inc. is seeking entry-level professionals for various roles in contract research focused on clinical trials involving pharmaceuticals, biologics, and medical devices.As an E-Verified organization, we welcome candidates on OPT and CPT, and we offer H1B (both CAP and CAP exempt) and Green Card sponsorship...

Position Overview:Katalyst HealthCares & Life Sciences Inc. is seeking entry-level professionals for various roles in contract research related to clinical trials involving pharmaceuticals, biologics, and medical devices.As an E-Verified organization, we welcome candidates on OPT and CPT, and we offer H1B (both CAP and CAP exempt) and Green Card sponsorship...

**Job Summary**US Tech Solutions is seeking a highly skilled Associate Regulatory Affairs Submission Management to join our team. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams.Key Responsibilities:Manage submission...

About Us:Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of...

Job SummaryXeris Pharmaceuticals, Inc. is seeking a highly experienced Senior Director to lead our Regulatory Affairs and Promotion team. As a key member of our organization, you will be responsible for developing and implementing strategies to ensure compliance with regulatory requirements and promoting our products effectively.Key...

Job title : CMC Regulatory Specialist [Must have Authoring Document Exp of Module III]Location: 100% RemoteDuration:12 monthsStrong working knowledge of manufacturing unit operations or CTD structure2. Experience project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure...

Overview The Senior Regulatory Affairs Manager for Advertising & Promotion plays a pivotal role in overseeing the regulatory components of both internal and external communications, specifically focusing on advertising and promotional initiatives. This position is responsible for orchestrating the formulation and execution of regulatory strategies that align...

Regulatory Affairs Specialist SeniorGentiva, a leading provider of healthcare services, is seeking a highly skilled Regulatory Affairs Specialist Senior to join our team.About the RoleThis is an exciting opportunity to contribute to the development and implementation of regulatory strategies that support our company's growth and compliance with government...

Job Summary:The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners.Key...

Home Search Jobs Job Description Regulatory Affairs Associate Contract: North Chicago, Illinois, US Salary: $30.00 Per Hour Job Code: End Date: Job Description: Key Responsibilities:Assist in the preparation of regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and Pharmaceuticals. Demonstrate proficiency in...

Home Search Jobs Job Description Regulatory Affairs Associate Contract Type: Temporary Location: North Chicago, Illinois, US Compensation: $30.00 Per Hour Job Overview: As a Regulatory Affairs Associate, you will play a crucial role in supporting regulatory submissions for various product categories including Food, FSMP, Enteral Nutrition, and...