Regulatory Affairs Associate
Connecting Talent 2 Opportunity
Job Title
Primary responsibilities of this role include the following:
- Interacts effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.
- Reviews technical documents for accuracy and with supervision, determines acceptability for use in NDAs, Amendments, Supplements, Annual Reports, Health Authority Meeting Requests and Briefing Packages and other required FDA filings in order to ensure high-quality submissions and expeditious approvals from FDA.
- Helps to compile high-quality, original NDAs, Amendments, Supplements, and Annual Reports.
- Assesses changes and their impact on the business based on an understanding of regulatory guidelines and applicable federal laws.
- Other duties as assigned.
Qualifications:
- Minimum of a Bachelor's Degree in life science.
- Minimum of 3 years in the pharmaceutical industry with 1-2 of those years in regulatory affairs.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Associate in Pine Brook, NJ vacancy
- ...Regulatory Affairs AssociateEssential Job FunctionsStay abreast of evolving regulations related to dietary supplements.Seek ways to improve the speed and accuracy of completing documentation requests.Research difficult or client issues and provide recommendations and...Suggested
Connecting Talent 2 Opportunity
Caldwell, NJ4 days ago - ...Job TitleParticipate in a multidisciplinary technical team to develop regulatory strategies and solutions for a wide range of Crop Protection & Nutrition clientsProvide support for the preparation and submission of applications to US EPA for registration of pesticides...SuggestedLocal area
Connecting Talent 2 Opportunity
Parsippany, NJ3 days ago - Duration: 03 months with possible extension Job Description: The purpose of the position is to identify and resolve compliance and eligibility issues with contracted managed care customers. This position works with the Market Access account managers and the contracted...SuggestedContract work
US Tech Solutions
Parsippany, NJ19 hours ago - ...Regulatory Compliance Specialist Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well... ...Life Sciences. ~1-2 years in the area related to Regulatory Affairs/Regulatory Operations ~ Experience in consumer products industry...Suggested
Integrated Resources
Parsippany, NJ3 days ago - Formulary Compliance AnalystThe purpose of the position is to identify and resolve compliance and eligibility issues with contracted managed care customers. This position works with the client's Market Access account managers and the contracted account to gain alignment...SuggestedContract work
eTeam
Parsippany, NJ15 hours ago - ...corporate registrations, business licenses, permits, and other regulatory requirements. Coordinate amendments, name changes, address... ...across the organization. Minimum Qualifications: ~ Associate's degree required; Bachelor's degree preferred. ~2-5 years of...Work at officeLocal area
VDA Inc
East Hanover, NJ2 days ago - Job Description: The purpose of this position is to identify and resolve compliance and eligibility issues with contracted managed care customers. This position works with Market Access Account Managers and contracted accounts to align on formulary product placement and...Full timeContract workLocal area
Rang Technologies Inc
Parsippany, NJ10 hours ago - ...and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or marketed...Immediate start
Artech
East Hanover, NJ3 days ago - ...Regulatory SpecialistIRI believes in commitment, integrity and strategic workforce solutions.Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business...
Careers Integrated Resources Inc
Parsippany, NJ3 days ago - ...Regulatory AssociateIntegrated Resources, Inc is a premier staffing firm recognized as one... ...requirements which support the launch of associated products within NA.Execute systems integration... ...involving federal and local government affairs.Review trade association materials (...Work experience placementWork at officeLocal area
Careers Integrated Resources Inc
Parsippany, NJ3 days ago $32.5 - $36 per hour
Job Description Overview\n Intuit is seeking highly motivated individuals to join our dynamic team as dedicated year-round TurboTax Retail Experts in one of our TurboTax Retail or Flagship locations across the United States. This unique opportunity combines tax expertise...Local areaIntuit
East Hanover, NJ18 days ago$205.62k - $266.09k
...office based/hybrid located in Foster City, CA or Parsippany, NJ. As the Sr Director, U.S. Ethics & Compliance Advisor, Medical Affairs, you will report into the Executive Director, U.S. Ethics & Compliance Advisor and you will... Act as the key point of ethics and...Full timeFor contractorsWork at officeLocal areaGilead Sciences
Parsippany, NJ3 days ago$205.62k - $266.09k
...role providing ethics and compliance guidance to U.S. Medical Affairs at a pharmaceutical company. Leads a team, partners across organizational... ...to integrate compliance programs, and ensures adherence to regulatory and ethical standards in medical-commercial interactions....Gilead Sciences
Parsippany, NJ1 day ago$20.5 per hour
Bilingual Document Processor / International Compliance Analyst Business Credentialing Services, Inc. (BCS) is a fast-growing technology company in the insurance and risk management industries. We are growing our Operations department and are looking to hire a Document...Hourly payFull timeWork experience placementWork at officeRemote workMonday to Friday2 days per week1 day per week- ...Regulatory Affairs Specialist Job Type: Full time - Permanent Location: Madison, New Jersey (On-site) A commercial-stage transplant technology company, part of a global medtech group, is changing how donor organs are preserved and assessed before transplant. Their...Permanent employmentFull time
Skills Alliance
Madison, NJ3 days ago $180k - $250k
...Pay: $180,000.00 - $250,000.00 per year Why This Is a Great Opportunity Step into a senior-level role where your healthcare regulatory expertise directly shapes client strategy and risk management. Serve as a trusted subject matter expert on sophisticated...Work at officeRemote workFlexible hoursOrion Placement
Roseland, NJ1 day ago- Priority Tax Relief is seeking a detail-oriented HR Coordinator to support onboarding, compliance, and HR operations. This role ensures new hires have a seamless introduction, while maintaining accurate personnel records and handling change workflows with precision. You...
Priority Tax Relief
Fairfield, Essex County, NJ3 days ago $124.48k - $155.6k
...process optimization, automation, and digital transformation, while ensuring alignment with business goals, enterprise standards, and regulatory requirements.*This role is 2-3 days onsite at our Parsippany, NJ office*The ideal candidate combines strong business analysis...Work at officeLocal areaWorldwideFlexible hoursTeva Pharmaceutical Industries
Parsippany, NJ4 days ago$120k - $165k
Actuary, Reserving - North America SpecialtyAt AIG, we are reimagining the way we help customers to manage risk. Join us as a Actuary, Reserving - North America Specialty, North America to take on key responsibilities within a world-class actuarial function.Make your mark...Full timeWork at officeLocal areaAmerican International Group (AIG)
Parsippany, NJ3 days ago- ...security, IT audit, compliance, or a related field. ~ Strong knowledge of at least two U.S. privacy, cybersecurity, or federal regulatory requirements, such as FTC regulations, CCPA/CPRA, COPPA, CIRCIA, or NIST frameworks. ~ Expertise in at least four areas including...Fixed term contract
RecruitHook
Nutley, NJ19 hours ago - ...processes, including controls certification, issues management, regulatory inventory reviews, policy management, and compliance... ...controls monitoring activitiesLog, track, and monitor issues and associated remediation activities through resolutionPrepare periodic reporting...Full timeContract workLocal area
Broadridge
Newark, NJ6 days ago $35 - $41 per hour
...continuous improvement, based on a detailed understanding of business processes, to establish, modify or maintain data structures and associated components (entity descriptions, relationship descriptions, attribute definitions). Ability to simplify complex problems and...Hourly payContract workUS Tech Solutions
East Hanover, NJ5 days ago$86.7k - $170.9k
Position Summary Consultant - Regulatory & Compliance - Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team... ...not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At...Local areaVisa sponsorshipDeloitte
Morristown, NJ3 days ago$128.56k - $155k
**Internal Candidate Identified**About ZoetisZoetis is a global animal health company dedicated to supporting customers and their businesses. Building on more than 60 years of experience, Zoetis delivers quality medicines and vaccines, complemented by diagnostic products...Full timeTemporary workLocal areaZoetis
Parsippany, NJ2 days ago- ...continuous improvement, based on a detailed understanding of business processes, to establish, modify or maintain data structures and associated components (entity descriptions, relationship descriptions, attribute definitions). Parter with Product Owners, BI...Contract workRemote work
The Fountain Group
East Hanover, NJ4 days ago - ...Regulatory Affairs SpecialistOrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes... ...activities related to GMP and ISO regulations and associated standards, as well as, assist in the performance of internal...Remote work
OrganOx
Madison, NJ4 days ago $129k - $154k
Associate Actuary - North America PropertyAt AIG, we are reimagining the way we help customers to manage risk. Join us as a Associate Actuary - North America Property to take on key responsibilities within a world-class actuarial function.Make your mark in ActuarialOur...Full timeWork at officeAmerican International Group (AIG)
Parsippany, NJ4 days ago$142.02k - $189.36k
About the Role:We have a current opening for a Category Controller, Kinder & FMC and are actively reviewing applications.As a Finance Category Controller Director you will provide strategic financial leadership across assigned categories, shaping category priorities and...Ferrero
Parsippany, NJ5 days ago$106.79k - $189.5k
Regulatory Affairs Compliance ManagerPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating through its subsidiaries, oil refineries and related facilities. We are seeking a talented Regulatory Affairs Compliance Manager to join...Full timeWork experience placementPBF Energy
Parsippany, NJ5 days ago$90.72k - $121.52k
...maintenance Effective collaboration and communication abilities with cross-functional teamsRequired Skill and Experience• Experience in Regulatory reporting /AML/ Capital Markets/Derivatives• Experience in Data Analysis, analyzing, validating and documenting business...Full timeTemporary workRelocationInfosys Technologies
Newark, NJ5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Associate. Be the first to apply!
