Senior Regulatory Affairs Lead - Drug Development & IND/NDA
US Tech Solutions
A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires a minimum of 5 years of experience in drug development, including direct management of new drug approvals. Responsibilities include regulatory guidance, communication with health authorities, and strategic planning for submissions. Join a dynamic team aiming for mutual growth and innovation in pharmaceutical projects. #J-18808-Ljbffr US Tech Solutions
$144.06k - $205.8k
...Through our research and development programs, we are... ...plays a key role in the regulatory affairs department. Responsible... ...regulatory frameworks (e.g., NDA strategy/planning for... ...meetings such as Pre-IND, IND, Pre-NDA, and NDA... ...pharmaceutical drug development experienceRecognized...SuggestedContract workWork at officeRemote workWork from homeWorldwide- ...North Chicago, IL site seeks a senior Clinical Pharmacology... ...execute novel PK/PD research, lead method development, and drive CPPM goals... ...development. You will steer regulatory science and contribute to program... ...in pharmacology and drug development. #J-18808-Ljbffr...Senior
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$125.09k - $178.7k
...women's health. Through our research and development programs, we are pioneering new healthcare... ...data analytics for informed decisions.As Lead, Operational Planning & Delivery, this... ...schedules, costs, and resources across the drug portfolio, enhancing performance. Responsible...SeniorWork at officeRemote workWork from homeWorldwide- AbbVie is seeking a Senior Scientist I to lead molecular profiling and solid-state drug delivery efforts within MPDD. You will drive solid form development, apply computational modeling, and collaborate with cross-functional teams to advance candidates through development...Senior
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- ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device products. You will analyze... ...have 7+ years in medical products, strong ability to lead regulatory arguments, and experience coordinating with RAs across...Senior
- A leading biopharmaceutical company seeks a Principal Research Scientist in North Chicago to support early phase development of synthetic peptides. The role involves mentoring staff, developing... ...collaborating across departments to advance drug candidates. Strong analytical...Senior
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- ...Safety Team (PST) lead for late stage... ...with the development medical lead, setting... ...leads, regulatory and clinical development... ...as medical affairs colleagues to help... ...of pre-NDA and NDA/sNDA submissions... .../ biological / drug -device... ...regulatory submissions (IND/BLA submissions...Senior
- ...@abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning...SeniorLocal area
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- AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Aesthetics Device to develop and execute regulatory strategies for on-market and development products in the US and Canada. You will coordinate lifecycle activities, interface with Health...
- ...Lipid Nanoparticle (tLNP) drug product development group within AbbVie’s tLNP... ...partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and... ...development capabilities, leading critical CMC activities... ...Purpose We are seeking a Senior Scientist to lead key scientific...SeniorTemporary workShift work
- ...YouTube. Job Description The Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME is... ...for oversight of complex product development within and across Therapeutic Areas... ...understanding of FDA requirements, drug development, and strong leadership...SeniorFull timeLocal areaImmediate start
- ...Job Description Biologics Drug Product Development (Bio DPD), a part of... ...candidate for the position of Senior Scientist II, located in North... ...Key Responsibilities: Lead the design and execution of... ...experience with authoring regulatory filings for biologics and sterile...SeniorFull timeTemporary workLocal area
- ...Analytical Research & Development (Analytical R&D) is a... ...advancement of industry-leading analytical... ...Description: For the Senior Scientist I position,... ...Chemical Entities (NCEs) drug substance in both preclinical... ...Assurance (QA) and CMC-Regulatory. This position...SeniorFull timeTemporary workLocal area
- AbbVie seeks a Senior Scientist II to independently conceive and execute novel scientific research in analytical development, focusing on transitioning NCEs and synthetic peptides... ...PCS, Process Chemistry, QA, and CMC-Regulatory affairs to deliver robust analytical capabilities...Senior
- AbbVie is seeking an Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) to partner with internal and external... ...for CMC to enable first-pass approvals and manage content for INDs/CTAs, supplements, and variations. You will collaborate...Senior
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$228.1k - $325.85k
...our research and development programs, we are pioneering... ...for a passionate drug developer and... ...iADCs). The Asset Lead has overall and... ...development, global/local regulatory submissions, and... ...leading IND/IMPD, NDA/MAA/BLA, or FDA Advisory... ...interaction with senior leadership and governance...Work at officeLocal areaRemote workWork from homeWorldwide$109.5k - $208.5k
Principal Scientist I, Biologics Drug Product Development Full-time Salary Min: 109... ...for the position of Senior Scientist II / Principal Scientist... ...manufacturing sites. Lead the design and execution of... ...experience with authoring regulatory filings for biologics and sterile...Full timeTemporary work- ...Job Description Biologics Drug Product Development (Bio DPD), a part of... ...candidate for the position of Senior Scientist II / Principal Scientist... ...manufacturing sites. Lead the design and execution of... ...experience with authoring regulatory filings for biologics and...Full timeTemporary workLocal area
- AbbVie seeks an NPI Manager to lead new product introductions from the front end through to site handover. You will coordinate R&D, Regulatory, Finance, and Engineering to translate opportunities into feasible business cases. The role is client-facing within AbbVie’s pipeline...Senior
$207.19k - $295.99k
...Through our research and development programs, we are... ...:The Global Medical Lead (GML), Biopharma and... ...to global regulatory submissions.Analyze,... ...therapy or pediatric drug developmentS. F.D.A. Pre-IND, IND, and BLA submission... ...Frequent interaction with senior leadership and...Work at officeRemote workWork from homeWorldwide
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