Senior Manager, CMC Regulatory Affairs - Biologics
BioSpace
BioSpace is seeking a Senior Manager in Regulatory Affairs to lead the CMC strategy for biologic products. Key responsibilities include preparing regulatory submissions, analyzing regulatory changes, and developing CMC strategies to ensure first-pass approvals. The ideal candidate should have 8+ years in the pharmaceutical industry, strong communication skills, and experience in regulatory affairs. Hybrid work is offered, with 3 days in office and 2 days remote at our North Chicago, IL headquarters. Comprehensive benefits include medical insurance, 401(k), and competitive base pay. #J-18808-Ljbffr BioSpace
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$109.5k - $208.5k
Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Full‑time Salary Min: 109,500 Salary Max: 208,500 Workday Global Grade: 18 Compensation:... ...for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead works with internal and external partners...SuggestedFull timeWork at office- ABBVIE is seeking a Manager for Regulatory Affairs focusing on Chemistry Manufacturing & Controls (CMC). The role requires preparing regulatory strategies and submissions, with responsibilities across product development teams. Candidates should possess a relevant bachelor...Suggested
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- ...experienced leader for Director/Associate Director, CMC Product Development to oversee multiple high... ...asset plans, and drive global filings and regulatory interactions. Responsibilities include steering PPDST/CMC activities, managing budgets and outsourcing contracts, and...Senior
- ...neuroscience. Job Description The Sr. Program Manager, CMC Portfolio Management leads the... ...Commercial. Additional duties involve Early Biologics Excellence pre‑clinical timeline support... ...Development Sciences organization to senior leaders and cross‑functional partners....SeniorLocal area
- ...Description The Quality Assurance Manager is responsible for providing... ..., combination products and biologics. This role will support the... ...deliver strategic plans and regulatory updates. This position will ensure... ...or compliance metrics to senior management.. Establish...Senior
- Allergan is looking for a highly motivated Senior Scientist II in North Chicago, IL, to lead biologics drug product formulation development. The successful candidate... ..., driving innovation and ensuring quality risk management within cross-functional teams. This position...Senior
$109.5k - $208.5k
Principal Scientist I, Biologics Drug Product... ...candidate for the position of Senior Scientist II / Principal... ...Development and CMC teams and will collaborate... ...stakeholders and line management. Support scale‑up and... ...experience with authoring regulatory filings for biologics...Full timeTemporary work$123k - $205.1k
...benefits, please click on the link below: Position Details As the Senior Manager of Export and Sanctions Compliance, you will be responsible... ..., and controls tailored to the company's risk profile and regulatory requirements. Function as a hands‑on operational leader for export...SeniorFull timeWork at officeLocal areaWorldwide3 days per week- Grainger in Lake Forest is hiring a Senior Manager of Export and Sanctions Compliance to oversee compliance with regulations across global operations. This role involves developing policies, providing operational support, and managing workflows around compliance investigations...Senior3 days per week
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- ...mechanistic understanding of drug safety across small molecules, biologics, and emerging modalities. This role sits at the intersection of... ...for both technical and non‑technical audiences Qualifications Senior Scientist I: Bachelor’s Degree and typically 10 years of...Senior
- Job Description Join AbbVie’s Biologics Discovery Sciences group and make a tangible impact in advancing innovative biologic therapies. As a scientist specializing in Biologics Purification, you will play a pivotal role in driving drug discovery, collaborating within a...SeniorWorldwide
- BioSpace is looking for a Senior Director of Regulatory Business Excellence in North Chicago, Illinois. The candidate will lead a cross-functional... ...processes at Abbvie, focusing on training, change management, and collaborative design. This role requires a strong background...Senior
- • Develops regulatory strategies for development projects, design changes... ...alignment with Regulatory Management as appropriate. • Acts as... ...of five years in regulatory affairs with direct experience and authoring... ...Degree required in pharmacy, biology, chemistry, pharmacology,...
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