Senior Regulatory Affairs Specialist
Breckenridge Pharmaceutical
Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing. You will develop and maintain templates, track regulatory records, and collaborate with cross-functional teams to align on FDA/ICH requirements and SOPs. The role offers a competitive package with flexible work options and comprehensive health benefits. #J-18808-Ljbffr
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Specialist in Berkeley Heights, NJ vacancy
$90k - $125k
...group’s own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting...SeniorFlexible hoursBreckenridge Pharmaceutical
Berkeley Heights, NJ21 hours ago$115k - $135k
...manufactures from around the world. Responsibilities Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs,... ...Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations. Knowledge of eCTD publishing systems and standards...SeniorWork at officeFlexible hoursBreckenridge Pharmaceutical
Berkeley Heights, NJ4 days ago- ...therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. Position Summary The Senior Regulatory Affairs Specialist is responsible for leading and supporting regulatory activities for assigned devices and projects throughout the...SeniorFlexible hours
OrganOx Limited
Madison, NJ2 days ago - Breckenridge Pharmaceutical, Inc. in the United States, seeks a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes), support lifecycle management, and assist the Director of Regulatory Affairs. Focus on complex generics...Senior
- ...hospital operations, and life sciences in more than 160 countries and regions. Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, INDs, IDEs and PMAs) for North America as...SeniorFor subcontractorRemote workFlexible hours
OrganOx
Madison, NJ5 days ago - Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing of regulatory documents ensuring conformance with Health Authority requirements. The role supports staff in document management and coordinates eCTD modules...Senior
$72k - $141k
...their fullest potential. The Compliance Senior Consultant is a strategic individual contributor... ...key compliance programs, enhancing regulatory responsiveness, and facilitating... ...experience in insurance, compliance, regulatory affairs, or audit.Demonstrated ability to...SeniorFull timeWork experience placementWork at office- ...Withum is experiencing significant growth driven by market demand for assurance services. Our team is seeking a Contract Compliance Senior Consultant with experience performing royalty audits, franchise compliance audits, revenue participation audits, lease agreement...SeniorFull timeContract workWork at officeLocal area
- By Landmark is seeking a senior Executive Assistant to support one of its founding Principals from our Plainfield base. You will manage a complex calendar, anticipate needs, and exercise discretion with high-level executive support across Landmark venues. Role requires...Senior
- Withum is seeking a Contract Compliance Senior Consultant for its Risk Advisory practice. The role focuses on royalty audits, franchise compliance audits, revenue participation audits, lease reviews, vendor audits, and related contract-based projects. The Senior Consultant...SeniorContract workWork at office
$119k - $218.3k
Position Summary Senior Consultant - Risk, Regulatory, & Licensing - Digital Assets Regulatory & Financial Risk Ready for a fast-paced, impactful... ...or certification(s) in risk, compliance, regulatory affairs, or a related field (e.g., CRCM, CAMS, CISA, JD, or LLM)...SeniorWork at office$90k - $200k
...Senior Manager, Financial InvestigationsKroll's North American Investigations, Diligence and Compliance practice is seeking a Senior... ...a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client)...SeniorTemporary workKroll
Morristown, NJ5 days ago$68k - $96.67k
...advise personnel on procedures to process Supply Chain transactions accurately. Ensure compliance with associated corporate and regulatory requirements, such as sales tax, SOX, IRS, FERC. Minimum Requirements Bachelor's degree in Supply Chain Management, Business...SeniorFull timeContract workTemporary workFlexible hoursXcel Energy
Union, NJ17 days ago- ...Executive AssistantThis is a senior Executive Assistant role supporting one of By Landmark's founding Principals. You will be the person who makes leadership run — managing a complex calendar, anticipating what's needed before it's asked for, and operating with the discretion...SeniorWork at officeWork from homeShift workAfternoon shift
Landmark Hospitality
Plainfield, NJ5 days ago $140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely...SeniorFull timeWork at officeLocal area- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research... ..., including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director MaSeniorFull time
Merck & Co.
Rahway, NJ2 days ago - Company DescriptionGrowing Consulting Firm is looking for young, sharp and talented Individuals to join their firm.Job DescriptionOur senior accountant will develop an understanding of the companies engagement approach, methodology & tools. The senior accountant will...Senior
- ...Senior Associate Attorney The Firm is seeking experienced associate attorneys with a fire in their belly to: give clients peace of mind that if a death or dying crisis happens their wishes will be enforceable; and, advocate fiercely for the vulnerable elderly and others...Senior
Saxon Global
Watchung, NJ3 days ago - ...Cloud Hybrid Technologies, LLC in New Jersey is seeking a senior IAM professional with deep expertise in identity and access management to design, implement, and operate large-scale Okta IAM solutions, including SSO, MFA, Passwordless, and adaptive security. You will...Senior
Cloud Hybrid Technologies LLC
Berkeley Heights, NJ4 days ago - Company DescriptionFortune 500 Retail CompanyJob DescriptionMUST HAVE PRIOR PUBLIC ACCOUNTING EXPERIENCEThis position is responsible for activities relating to the Corporation’s global intercompany reconciliation, elimination, and reporting processes. - Perform duties as...SeniorTemporary workFlexible hoursShift work
- ...PSEG Services Corp. in New Jersey is seeking an Accounts Payable Specialist to handle invoice processing and payments within a hybrid work model. Your duties include auditing, document organization, and ensuring Sarbanes-Oxley compliance. This role emphasizes accuracy...Senior
PSEG
Plainfield, NJ1 day ago - ...Hikma Pharmaceuticals USA Inc. seeks a Senior Manager, Business Development to drive new growth opportunities in the US market. You will build financial models, evaluate in-licensing opportunities, and support M&A with cross-functional teams. The role offers exposure...Senior
Hikma Pharmaceuticals
Berkeley Heights, NJ5 hours ago - ...and infrastructure. The role blends technical depth, pharma domain knowledge, and consulting maturity to operate independently at senior levels. Senior FDEs will scale engagements, mentor junior engineers, and contribute to reusable accelerators and reference architectures...Senior
Axtria
Berkeley Heights, NJ5 hours ago - ...laboratories translate biomarker strategies into fit-for-purpose clinical assays that inform target engagement, mechanism of action, patient selection, pharmacodynamic response, and clinical outcomes.The Molecular Pathology Laboratory Lead is a senior scientific and peopleSeniorFull time
Merck & Co.
Rahway, NJ2 days ago $117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines...For contractorsLocal area- Jacobs is seeking a Major Crossings Design-Build Principal to lead pursuit, planning, and execution of major bridge and transportation projects across the US. You will guide multidisciplinary teams, manage design-build delivery, and develop client relationships, ensuring...Senior
- Senior Data EngineerBigdata, Java, Spark, Kafka – Berkeley Heights NJ– ApexST / Client – ONSITE - LOCAL/Nearby Experience in Java Programming and in Big data technologies with hadoop, spark, kafka, AZURESeniorLocal area
Keylent Inc
Berkeley Heights, NJ5 days ago $130k - $165k
Interstate Waste Services is seeking a Manager of Hauling Operations in Plainfield, NJ, to oversee depot functions, manage personnel, and ensure operational efficiency. The ideal candidate will have extensive experience in transportation/logistics and the ability to enhance...SeniorInterstate Waste Services
Plainfield, NJ4 days ago- A technology consultancy in New Providence, NJ, is seeking a Technical Architect - PHP for a 6-month contract. The ideal candidate will have over 5 years of experience in designing and developing web-based solutions using PHP, along with strong skills in ORM and SOA. You...SeniorContract work
Georgia IT Inc
New Providence, NJ4 days ago - Senior Java DeveloperLocation: Charlotte, NCOnsite: 3 days a weekInterview process: screening then final video interviewContract: 6-24 months to permMust have: Core Java, Angular or React (not much), Streams, N + 1 query, microservices, Spring and SQL.Senior
RIT Solutions
Summit, NJ5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist. Be the first to apply!
Related searches
- senior application security Berkeley Heights, NJ
- senior Berkeley Heights, NJ
- senior operations technician Berkeley Heights, NJ
- senior robotics software engineer Berkeley Heights, NJ
- senior database analyst Berkeley Heights, NJ
- senior manager tax Berkeley Heights, NJ
- senior financial analyst fp&a Berkeley Heights, NJ
- international tax senior Berkeley Heights, NJ
- senior project manager contract Berkeley Heights, NJ
- senior software engineer ruby on rails Berkeley Heights, NJ