Associate Director, CMC Regulatory Strategy
BioSpace
AbbVie seeks an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to lead regulatory strategies and submissions. You will collaborate with internal and external partners to deliver products, negotiate with agencies, and guide teams on first-pass approvals across INDs/CTAs and variations. The role emphasizes strategic liaison with agencies (e.g., FDA), content strategy for submissions, and cross-functional collaboration with R&D, Operations, and product teams. #J-18808-Ljbffr BioSpace
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Associate Director, CMC Regulatory Strategy in North Chicago, IL vacancy
- AbbVie is seeking an Associate Director of Regulatory Affairs, CMC, to lead strategic regulatory activities and author regulatory submissions for complex... ...requires extensive experience with global regulatory strategies, strong communication skills, and the ability to...Suggested
- AbbVie in the United States is seeking a Manager, Regulatory Affairs for CMC to lead regulatory strategies and submissions. You will work with RA, R&D, and Operations to enable first-pass approvals and manage change controls, maintaining alignment with global guidelines...Suggested
- ...Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on... ...US and Canada regulatory requirements. Assures that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are...Suggested
- AbbVie in the United States is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for drug products. You will collaborate with internal teams and external partners, negotiating with agencies to enable first-pass approvals...Suggested
- AbbVie in North Chicago is seeking an experienced Associate Director for CMC Portfolio Management. The role involves leading project management for complex drug development projects and mentoring junior staff while ensuring strong communication across teams. The ideal...Suggested
- AbbVie in North Chicago, IL seeks an Associate Director Regulatory Affairs, CMC to lead regulatory strategies for chemistry, manufacturing and controls and to coordinate submissions (INDs, CTAs, variations) with global teams. You will influence FDA interactions, manage...
- ...YouTube. Job Description The Associate Director, CMC Portfolio Management leads with the development... ...for Product Presentation & Device Strategy Teams (PPDST) using standardized... ...solutions to R&D (Development Sciences, Regulatory, etc). Develop and provide advanced...Full timeWork experience placementLocal area
AbbVie Inc.
North Chicago, ILmore than 2 months ago - ...Individual is responsible for ensuring RA-CMC post approval change objectives are met... ...functional departments in support of regulatory filings. This position will manage, coach... ...develop initial content plans, bundling strategies, and project timelines. Partner with RA...
- ...Instagram, X and YouTube. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners... ...products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops...
- ...organization that includes CMC (Process R&D, Drug Product Development... .... The Data & Digital Strategy CORE team within Development... .... Role Overview: The Associate Director, Strategy Lead for Submission... ..., Development Sciences, Regulatory Affairs, and IT to understand...Full timeLocal area
AbbVie Inc.
North Chicago, ILa month ago - ...Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of... ...collaborators, incl. Clinical, Regulatory, Operations, Quality,... ...Qualifications for Director, CMC Product Development... .... Qualifications for Associate Director, CMC Product Development...Work experience placement
AbbVie
North Chicago, IL4 days ago - ...Facebook, Instagram, X and YouTube. Job Description The Associate Director of Neuroscience Commercial Strategy - Corporate Business Strategy Office (CBSO)will... ...(MABI), Sales Training, Sales Force Effectiveness, Regulatory, Customer Experience, and other cross franchise...Work at officeLocal area
Allergan
North Chicago, IL2 days ago - AbbVie seeks an Associate Director I, Process Development (External Manufacturing) to lead and shape external manufacturing strategies for small molecules across a global CRO/CDMO network. The role focuses on early- and mid-stage development, phase-gate governance, and...
$200k - $235k
...- Open to candidates within the United States The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to... ...regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion...Work at officeRemote workFlexible hoursLundbeck
Deerfield, IL2 days ago- Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies... ...taking leadership roles in professional associations, industry, and trade groups as appropriate...Worldwide
- ...Instagram , X and YouTube. Job Description The Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME is responsible for... ...Participates in and takes leadership roles in professional associations, industry and trade groups as appropriate for assigned...Full timeLocal areaImmediate start
AbbVie Inc.
North Chicago, ILa month ago - ...Individual is responsible for ensuring RA-CMC post approval change objectives are met... ...functional departments in support of regulatory filings. This position will manage, coach... ...develop initial content plans, bundling strategies, and project timelines. Partner with RA...Full timeLocal area
- ...Instagram , X and YouTube. Job Description Purpose Statement The Associate Director of the Procurement Management Office (PMO) supports the Vice President of Procurement Strategy and Capabilities (PSC), the PSC Leadership Team and the Procurement Leadership...Full timeWork at officeLocal area
AbbVie Inc.
North Chicago, ILmore than 2 months ago - AbbVie in North Chicago, IL is seeking a Manager, Regulatory Affairs for CMC to lead regulatory strategies and submissions, collaborating with RA, R&D and Operations to drive first-pass approvals. You will mentor teams and align products with evolving regulatory requirements...
- AbbVie in North Chicago, IL seeks an experienced RA-CMC professional to lead post-approval change activities, coordinating cross-functional teams and authoring CMC sections for regulatory submissions. You will coach junior staff, manage timelines, ensure CTD formatting,...
$165k - $185k
...journey of growth! Remote/Commuter Opportunity - Open to candidates within the United States SUMMARY: The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and...Work at officeRemote workFlexible hoursLundbeck
Great Lakes, IL2 days ago- ...pipeline, primarily in the retina therapeutic area space. The Associate Director will play an integral role in helping to shape & progress... ...cross‑functional strategic portfolio planning & pipeline asset strategy development. The Associate Director will report to the Eye...Local area
AbbVie
Mettawa, IL4 days ago - ...please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Associate Director, HUB Strategy – Access & Reimbursement Solutions is a strategic and operational leader responsible for delivering operational...Full timeLocal area
AbbVie Inc.
Mettawa, ILmore than 2 months ago - ...at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Associate Director, US Market Access, Payer Strategy will lead development, evolution, and deployment of the VYALEV Integrated Access Strategy to support business...Full timeLocal area
AbbVie Inc.
Mettawa, ILa month ago $141.5k - $268.5k
...AbbVie has implemented important strategies and policy changes to tackle... ...340B Strategy and Innovation Associate Directorreports to the 340B Strategy and Innovation Director and is an expert in the... ...findings. Monitor statutory and regulatory changes related to the 340B...Full time- ...Instagram , X and YouTube. Job Description The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products... ...will design and deliver optimized global regulatory strategies, plans and dossiers that align with AbbVie’s overall...Full timeWork at officeLocal area
AbbVie Inc.
Mettawa, ILmore than 2 months ago - ...on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...Full timeWork at officeLocal area
AbbVie Inc.
Mettawa, IL22 days ago $165k - $230k
Associate Director, Global Quality and Compliance Excellence BioSpace - AbbVie - North Chicago,... ...regulations to lead preparedness for regulatory inspections and audits at AbbVie sites... ...component of AbbVie's overall compliance strategy. Collaborates with Quality Centers of...Full timeTemporary workLocal area- AbbVie in North Chicago, IL is seeking a Director Regulatory Affairs Global Regulatory Lead to drive global strategies for development and lifecycle management. You will lead the GRPT and collaborate with cross‑functional teams to ensure regulatory readiness and compliant...
- ...function within the Small Molecule CMC organization is accountable... ...advise clinical formulation strategy. From candidate selection... ...teams to ensure successful regulatory submissions.... ...Job Description The Associate Director of Biopharmaceutics leads a...Full timeTemporary workWork experience placementLocal area
AbbVie Inc.
North Chicago, ILa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, CMC Regulatory Strategy. Be the first to apply!
Related searches
- associate director clinical operations North Chicago, IL
- associate scientific director North Chicago, IL
- associate manager North Chicago, IL
- associate director clinical data management North Chicago, IL
- associate strategy director North Chicago, IL
- remote associate product manager North Chicago, IL
- associate director contracts North Chicago, IL
- associate director North Chicago, IL
- regulatory manager North Chicago, IL
- director global regulatory affairs North Chicago, IL