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
- ...Overview: AbbVie Development Sciences (Dev Sci)... ...CMC (Process R&D, Drug Product... ...Director, Strategy Lead for Submission Automation... ...submissions (e.g. INDs, BLAs) across modalities... ...Sciences, Regulatory Affairs, and IT to understand... ...reports directly to the Senior Director,...SuggestedFull timeLocal area
$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$124.5k - $236.5k
...YouTube. Job Description This Senior Business Systems Engineer, AI Capability Lead will provide independent... ...technical decision support for Medical Affairs and Health Impact (MHI) and... ...teams, engineering teams, and IR development organizations. Responsibilities...SeniorFull timeLocal area- ...Description Biologics Drug Product Development (Bio DPD), a part of Development... ...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...SeniorTemporary workLocal area
- ...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...SeniorFull timeTemporary workLocal area
- ...Job Description Biologics Drug Product Development (Bio DPD), a part of... ...candidate for the position of Senior Scientist I, Biologics Drug... ...manufacturers. Responsibilities Lead the design and execution of... ...of relevant cGMP and regulatory guidance. Experience...SeniorFull timeTemporary workLocal area
- ...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
- ...organization in research & development, R&D Quality Assurance (... ..., industry innovation, regulatory landscape, and AbbVie’s... ...overall success of drug/device development programs. Senior Manager, Safety, Medical... ...global Safety, Regulatory Affairs (RA) or Medical Affairs...SeniorFull timeLocal areaWorldwide
- ...safety profile of our drugs to protect patients worldwide... ...high-impact team that leads and owns safety... ...program reviews to ensure regulatory compliance and... ...and contribute to team development efforts. Show strong... ...stakeholders, including senior leaders and physicians...SeniorFull timeWork at officeLocal areaWorldwide
- ...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
- ...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...SeniorLocal area
- ...Job Description The Senior Business Systems Analyst, AI... ...emerging AI capabilities in BTS, Development Sciences. This role... ...supporting dossier submissions (e.g. INDs, BLAs) across modalities... ...dossier management, Regulatory Affairs, and IT to understand and deliver...SeniorTemporary workLocal area
- ...on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP)...SeniorFull timeLocal area
- ..., Facebook , Instagram , X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning...SeniorFull timeLocal area
$160.5k - $305k
...AbbVie's Research and Development Process Engineering team... ...and we're looking for a Senior Principal Research... ...of what's possible in drug product development. This... ...ready to raise the bar, lead with influence, and leave... ...s safety, quality, and regulatory standards....SeniorFull timeWork experience placementLocal area- ...the focus and passion of a leading-edge biotech with the expertise... ...Chemistry is seeking a Senior Principal Research Scientist... ...conduct process research and development of drug conjugates, peptides, and small... .... Author and review key regulatory documents, laboratory data,...SeniorFull timeWork experience placementLocal areaWorldwide
- ...generate a comprehensive safety assessment for early drug development programs. Responsibilities Provide scientific... ...Ability to function in multidisciplinary teams to address regulatory queries. Serves and/or leads issue resolution teams and participates in due...SeniorLocal area
- ...Organization, a part of AbbVie’s Development Sciences organization,... ...processes to make drug substances and drug... ...justification of CMC regulatory content. Job... ...collaborations. In addition to leading the technical team,... ..., and regulatory affairs specialists. Author...SeniorTemporary workWork experience placementLocal area
- ...The Analytical Development group within the Targeted... ...critical support to tLNP drug substance, drug product... ...Quality Assurance and CMC-Regulatory Affairs. Responsibilities:... ...activities. Lead and execute characterization... ...documents, such as IND and comparability study...SeniorTemporary workLocal area
- ...YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls... ...regulatory submissions, including INDs/CTAs and amendments, new marketing applications... ...areas, Operations and Research & Development (R&D) organizations. Represents CMC...SeniorFull timeWork at officeLocal areaRemote work
- ...R&D organization, the Senior Director, Project Management... ...role with the Development TA Vice President (TA... ...incumbent is responsible for leading development of the... ...technologies (e.g., biomarkers, drug delivery systems,... ...environment (e.g. regulatory trends, changing payer...SeniorFull time
- ...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
- ...experienced Director to lead the Lake County Combination Product Development (CPD) team and serve as... ...excellence in device and drug-device platform development... ...stakeholders (R&D, Regulatory, Quality, Operations, Supply... ..., and influence senior/global stakeholders....Full timeContract workLocal area
- ...Instagram , X and YouTube. Job Description The Senior Associate, Regulatory Affairs Submission Management , manages medium to high impact,... ...Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications...SeniorTemporary workWork at officeLocal areaRemote work
- ...practices to complex business situations, and contributes to team development by coaching staff and building strong relationships with key... ...creation activities.May coach and mentor more junior analysts. Leads and trains staff members on new and existing tax processes and...SeniorHourly pay
- ...Outcomes Research (HEOR) leads the strategic development & execution of high-quality... ...and ability to engage with senior leaders in a cross... ...downs associated with new drug development or on-market product... ...Extensive knowledge of the global regulatory, HTA and PR&A landscape,...Full timeTemporary workWork experience placementLocal area
$129.3k - $258.7k
...spectrum of healthcare, with leading businesses and... ...have access to:Career development with an international... ...Medical & Scientific Affairs organization.We’re empowering... ...Clinical Development, Regulatory, Marketing, and... ...influencing skills with senior internal and external...WorldwideShift work$144.06k - $205.8k
...health. Through our research and development programs, we are pioneering... ...& Scope As the Chapter lead - Digital Market Access & Revenue... ...based on the business value, regulatory requirements and evolving business... ...compliance with Medicaid Drug Rebate Program, 340B, and...Contract workWork at officeWork from homeWorldwide- ...novel scientific research or development in Clinical Pharmacology that... ...Generate new PK/PD proposals and lead those efforts. Investigate,... ...Pharmacology, PK/PD and regulatory advances and integrate this knowledge... ...or systems pharmacology, Drug metabolism/Transporters)...SeniorLocal area
- ...Description The role of Senior Counsel, Global... ...you to navigate regulatory complexity, assess... ..., Sales, Medical Affairs, Regulatory... ...law. Support the development and implementation... ...Counsel, Oncology Lead. Qualifications... ...regulations impacting drug registration and...SeniorLocal areaShift work3 days per week
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