Regulatory Associate
LanceSoft Inc
Job Description Title: Regulatory Associate
Pay Rate $47.00 49.15/hr on W2
Location: Warren, NJ 07059 (Onsite or 3 days in office - Hybrid)
Duration: 06 Months
Day Shift: 8 am - 5 PM Job Description:
Regulatory Affairs Senior Associate
The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle. Maintenance for the portfolio of products defined by the US Business Units.
Key Responsibilities:
Qualifications:
Additional Preferred Qualifications:
Competencies and Skills:
Pay Rate $47.00 49.15/hr on W2
Location: Warren, NJ 07059 (Onsite or 3 days in office - Hybrid)
Duration: 06 Months
Day Shift: 8 am - 5 PM Job Description:
Regulatory Affairs Senior Associate
The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle. Maintenance for the portfolio of products defined by the US Business Units.
Key Responsibilities:
- These responsibilities include some of the following...
- Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph,
- NDA).
- Develop regulatory strategies and documents for new product launches and maintenance of current products
- aligned with the regulations
- Develop regulatory label for OTC products, review claims and copy
- Participate in the review of promotional materials
- Support end-to-end regulatory compliance of products in remit.
- Applies system and procedure updates to maintain up to date technical product records
- Identifies and participates in process improvements within US Regulatory Affairs
- Interact with colleagues in other global functions to support global programs
- Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete
- submissions
- Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends
Qualifications:
- Bachelor s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience
- 2-4 years experience in regulatory affairs including chemistry, manufacturing and controls, and over the
- counter experience, preferably within a Client/Consumer Healthcare/Pharma related industry.
- Experience and knowledge in Quality, product development and manufacturing areas.
- Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls
- Proficient knowledge in US FDA regulations
- Regulatory Affairs Senior Associate
- Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams
- Ability to manage prioritize projects of high complexity
- Experience leading end-to-end regulatory process in new product launches
Additional Preferred Qualifications:
- Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devices
- Ability to ensure compliance standards and key performance indicators are met
- Regulatory expertise in knowledge of the regulatory lifecycle
- Ability to interact at many levels
- Technical knowledge
- Minimum 2 years of experience in regulatory affairs
Competencies and Skills:
- Agile, attention to detail, written and verbal communication skills using evidence and applying judgement to
- balance pace, rigor and risk
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Associate in Warren, NJ vacancy
$45 - $49 per hour
...Our client, a leading organization in the Consumer Healthcare/Pharmaceutical industry, is seeking a Regulatory Affairs Senior Associate to join their team. This role will support the U.S. Regulatory Affairs function, focusing on OTC product registrations and lifecycle...SuggestedHourly payShift workManpower Group Inc.
Warren, NJ14 hours ago- ...The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle and maintenance for the portfolio of products defined by the US Business Units. Key Responsibilities: Represent USRA on assigned projects, provide guidance...Suggested
Xcede
Warren, NJ1 day ago - ...Europe and Asia enables us to be a powerful contributor and connector of right Talent. Job Description Description: The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines...Suggested
$30 - $36 per hour
Job Title: Regulatory Affairs Associate I Position Type: Contract (12+ Months) Location: Clark, NJ 07066 Salary Rate: $30-36/hour Job Description We are seeking a detail-oriented Regulatory Affairs Associate I to support regulatory compliance activities for products distributed...SuggestedContract workWork experience placement- Bank of America is hiring a Financial Solutions Advisor Stage I to enhance financial lives through personalized advice and support. This role involves obtaining necessary Securities Industry licenses and progressing through various stages of development in client management...Suggested
$175k - $215k
...Title: AVP, Senior Regulatory & Governance Risk Management Specialist Company: Everest Global Services, Inc. Job Category: Risk Management Job Description: About Everest: Everest is a global leader in risk management, rooted in a rich, 50+ year...Full timeEverest Insurance®
Warren, NJ2 days ago$90k - $125k
...partnerships with manufactures from around the world. *** OPEN TO RELOCATION TO NEW JERSEY *** About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting...RelocationFlexible hoursBreckenridge Pharmaceutical
Berkeley Heights, NJ2 days ago$98.35k - $115.7k
At U.S. Bank, we’re on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed. We believe it takes all of us to bring our shared ambition to life...Temporary workWork at officeLocal area3 days per weekU.S. Bank
Edison, NJ2 days ago- Job Opportunity At U.S. Bank At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed. We believe it takes all of us to bring...Temporary workWork at office3 days per week
U.S. Bancorp
Edison, NJ2 days ago $49.15 per hour
...Job Title: Regulatory Affairs Senior Associate Location: Warren, NJ Type: 6-month Contract Compensation: $49.15 hourly Contractor Work Model: Hybrid – onsite and remote Hours: 8am-5PM, 40 hours per week Overview The purpose of this role is to execute...Hourly payContract workFor contractorsLocal areaRemote work- Merck & Co. is seeking an Associate Specialist of Regulatory Planning & Publishing for its Rahway, NJ office. This hybrid role requires collaboration on regulatory submissions, ensuring high quality and timely deliveries. Key responsibilities include planning, execution...Work at officeFlexible hours
- Regulatory Affairs Coordinator - International Registrations (Medical Devices) - ClinChoice, Raritan, NJ. Position Summary We are seeking an entry‑level Regulatory Affairs Coordinator to support the international registration of our medical devices. This role focuses...InternshipWork at officeWorldwide
- A leading regulatory compliance firm is seeking a detail-oriented Regulatory Affairs Associate I to support compliance activities for products distributed in the United States and Canada. The role involves reviewing product formulas and artwork for regulatory compliance...Contract work
- ...Job Title: Regulatory Affairs Specialist Duration: 12 months, potential extension Remote Preferred Ideal Locations: Rochester, NY, Clearwater, FL, St Louis, MO, or Bridgewater, NJ Day shift- Monday to Friday must be available to work EST hours Description...Work at officeRemote workMonday to FridayDay shift
Spectraforce Technologies
Bridgewater, NJ4 days ago $70k - $80k
...and to generate business insights Prepare and present findings to actuarial and business leadership. Ensure compliance with regulatory and internal standards. Qualifications: ~ Bachelor's degree in Actuarial Science, Mathematics, Statistics, Data Science...Temporary workLocal areaFlexible hoursMSIG Holdings Inc
Warren, NJ2 days ago- Role Name - Data Analyst ROLE_DESCRIPTION - Detail-oriented Technical Data Analyst responsible for interpreting data, analyzing results, and providing actionable insights to drive informed decision-making. Work closely with IT & business stakeholders to...
Diverse Lynx
Warren, NJ1 day ago - Job Title In-Person Interview. Overall min. of 7 years experience on Data Side and minimum 3 years current experience in reinsurance. Well versed with data mapping and supporting data apps. Engage with stakeholders to document detailed requirements for data...
The Dignify Solutions, LLC
Warren, NJ5 days ago $152k - $200k
...pricing, experience studies, and management reporting Collaborate with external consultants and internal partners on filing and regulatory-related matters, as appropriate Manage, mentor, and develop two direct reports, promoting strong technical standards,...Full timeEverest Insurance®
Warren, NJ1 day ago£75k - £125k per year
Posted: 09/04/2026 Location: Warren, New Jersey, United States Salary: £75000 - £125000 Job type: Permanent Company Overview A globally recognised reinsurance business, headquartered in the US, is looking to strengthen its International Reserving function...Permanent employmentJCW Group
Warren, NJ4 days ago$150k - $200k
Actuary Opportunity At MSIG USA MSIG USA is the US-based subsidiary of MS&AD Insurance Group Holdings, Inc., one of the world's top P&C carriers and a global Class 15 insurer, with A+ ratings and a reach that spans 40+ countries and regions. Leveraging our 350-year ...Contract workTemporary workLocal areaFlexible hoursShift workMSIG Holdings Inc
Warren, NJ5 days ago$100k - $142k
Actuarial Consultant You have a clear vision of where your career can go. And we have the leadership to help you get there. At CNA, we strive to create a culture in which people know they matter and are part of something important, ensuring the abilities of all employees...Work experience placementCNA
Warren, NJ3 days ago$86.5k - $129.5k
...The Compliance Manager is responsible for ensuring adherence to regulatory requirements and internal policies within the transportation... ...Human Resources. DSV will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be...Temporary workLocal areaFlexible hoursDSV
Iselin, NJ4 days ago- Compliance Specialist, Equipment Commissioning & Qualification The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi-use sites through interaction with internal ...
TTI of USA
Summit, NJ5 days ago $30 - $40 per hour
...) - 117850 Time Type: Full Time Summary: The Compliance Specialist is responsible for supporting and ensuring adherence to regulatory requirements and internal policies within the transportation and logistics industry. They assist in developing and implementing compliance...Hourly payFull timeWork experience placementWork at officeLocal areaDSV
Iselin, NJ1 day ago- ...The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small...Work at officeLocal area
Omni Inclusive
Summit, NJ2 days ago - ...questions from other departments of the bank. Facilitate the completion of compliance related projects. Assist in managing Regulatory Compliance Examinations. Required Skills: Intermediate to advanced PC skills for Microsoft Office -- Word, Excel, and...Work at office
Valley National Bancorp
Morristown, NJ3 days ago - Attalon / Location Overview Attalon is a leading technology partner to the global aerospace and defense industry, specializing in lasers and precision optics. With over 500 employees in the U.S., Attalon engineers critical optical, laser, and coating technologies ...Contract workFor contractorsWork experience placement
Attalon
Warren, NJ1 day ago - Pinnacle Clinical Research in Springfield, NJ is seeking a Quality Associate to ensure the quality of clinical trials. Responsibilities include performing audits, ensuring compliance with regulations, and training site staff. Candidates should have a Bachelor's Degree in...
$70k - $75k
Regulatory Compliance Specialist Base pay range: $70,000.00/yr - $75,000.00/yr The Regulatory Compliance specialist, in this highly detail... ..., ingredient specifications, and certifications. The associate also supports regulatory and customer compliance programs, religious...Full timeWork at officeImmediate start$70k - $75k
The Regulatory Compliance Associate, in this highly detail‑oriented role, is responsible for coordinating the workflow of domestic and international product labeling projects, maintaining all project documentation, obtaining required approvals, and communicating new and...Full timeWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Associate. Be the first to apply!
Related searches