Current jobs related to Regulatory Affairs Associate - Tarrytown - Emerge Talent Cloud
-
Regulatory Affairs Specialist
2 days ago
Tarrytown, New York, United States Emerge Talent Cloud Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Emerge Talent Cloud. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our marketed products with regulatory requirements.Key ResponsibilitiesRegulatory Compliance: Ensure that our products comply with relevant...
-
Lead Regulatory Affairs Strategist
1 week ago
Tarrytown, New York, United States Regeneron Pharmaceuticals Full timePosition Overview:The Lead Regulatory Affairs Strategist will collaborate closely with the Global Regulatory Liaison (GRL) to provide comprehensive support in all facets of regulatory affairs pertinent to the advancement of innovative therapeutics. This includes ensuring adherence to quality standards, as well as navigating preclinical and clinical drug...
-
Regulatory Compliance Supervisor
2 weeks ago
Tarrytown, New York, United States Citizens Bank Full timeRegulatory Compliance Supervisor - Marketing & Advertising Overview: In this pivotal role, you will lead a dedicated team focused on ensuring adherence to industry regulations and internal policies. Key Responsibilities: Oversee compliance initiatives within the marketing and advertising sectors. Develop and implement strategies to mitigate risks associated...
-
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeJob SummaryThe Associate Manager, Medical Education – Data Analytics, is a key role within Regeneron Pharmaceuticals, Inc. that focuses on leveraging data-driven processes to measure the impact of medical education on an adult learning continuum.Key ResponsibilitiesManage data collection processes, including collaboration with external grant recipients and...
-
Compliance Officer
2 days ago
Tarrytown, New York, United States Emerge Talent Cloud Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Emerge Talent Cloud. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our marketed products with regulatory requirements.Key ResponsibilitiesRegulatory Compliance: Ensure that all products are in compliance...
-
Associate Manager, Medical Education
3 months ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeThe Associate Manager, Medical Education – Data Analytics, is responsible for data-driven processes to measure the impact of medical education on an adult learning continuum. This includes the collection, assessment, and aggregation of de-identified learning outcomes from grant supported medical education activities requiring coordination with multiple...
-
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timePosition: Medical Education Data Analytics Associate ManagerThe Medical Education Data Analytics Associate Manager plays a crucial role in employing data-driven methodologies to evaluate the effectiveness of medical education across the adult learning spectrum. This position involves the systematic collection, evaluation, and synthesis of anonymized learning...
-
Senior Quality Assurance Manager
3 months ago
Tarrytown, United States Emerge Talent Cloud Full timeJob DescriptionJob DescriptionPrestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the...
-
Executive Director, Biostatistics
3 weeks ago
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeThe Executive Director, Biostatistics (CDU–Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&D, and other key functions at...
-
Executive Director, Biostatistics
3 weeks ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeThe Executive Director, Biostatistics (CDU–Biostatistics Head, Internal Medicine) leads the statistical team for the assigned Clinical Development Unit, in partnership with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs, Development Operations and Development Program Management, R&D, and other key functions at...
-
Data-Driven Medical Education Manager
2 days ago
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeJob SummaryThe Associate Manager, Medical Education – Data Analytics, is a key role within Regeneron Pharmaceuticals, Inc. that focuses on leveraging data-driven processes to measure the impact of medical education on an adult learning continuum.Key ResponsibilitiesManage the data collection processes, including working with external grant recipients to...
-
Manager of Medical Education Analytics
5 days ago
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timePosition: Associate Manager, Medical Education - Data AnalyticsThe **Associate Manager, Medical Education - Data Analytics** plays a crucial role in implementing data-centric strategies to evaluate the effectiveness of medical education throughout the adult learning spectrum. This position entails the collection, evaluation, and synthesis of anonymized...
-
Head of Digital Transformation
2 days ago
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeAbout the RoleWe are seeking a highly experienced and innovative leader to join our team as the Director, Digital Solutions. This pivotal role will play a key part in our digital transformation journey, driving the exploration of cutting-edge technologies and the development of tailored solutions to drive innovation at Regeneron.Key ResponsibilitiesLead...
-
Associate Director, Clinical Pharmacology
1 month ago
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeWe are looking for an Associate Director, within our Clinical Pharmacology group.Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings.Provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team.Draft, finalize, and/or review clinical pharmacology study reports...
-
Product Packaging Specialist
1 week ago
Tarrytown, New York, United States Emerge Talent Cloud Full timeJob OverviewThe Packaging Engineer role focuses on the development and management of packaging solutions for consumer products. This position is crucial in ensuring that products are delivered safely and effectively while meeting quality and regulatory standards.Key Responsibilities:Design and implement innovative packaging solutions for new product...
-
Associate Director, Oncology Sales Forecasting
1 month ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeRegeneron is seeking an Associate Director, Sales Forecasting & Analytics to act as a leading business partner to the Commercial functions responsible for supporting financial and operational decisions that may impact product and business unit revenue. In this role you will be responsible for the generation, analysis, tracking and dissemination of the...
-
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeRegeneron Pharmaceuticals, Inc. is seeking a seasoned professional to serve as a key business partner to the Commercial functions, providing critical support for financial and operational decisions that impact product and business unit revenue. In this role, you will be responsible for generating, analyzing, tracking, and disseminating commercial revenue...
-
Director, Digital Solution Partner
3 months ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeThe Director, Digital Solutions is poised to be a pivotal role in our digital transformation endeavor. You will lead the charge in exploring cutting-edge technologies, investment in alliance to co-create and design solution tailored for Regeneron to drive the next wave of innovation. You will identify the most promising use cases across business domains,...
-
Quality Assurance Specialist
4 weeks ago
Tarrytown, United States Emerge Talent Cloud Full timeJob DescriptionJob DescriptionPrestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the...
-
Assoc Scientist, Protein Biochemistry
3 months ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc. Full timeRegeneron's Protein Biochemistry group, located in Tarrytown NY is seeking a highly motivated Associate Scientist. In this role, you will be driving a variety of assays to characterize protein and gene therapy candidates (AAV/pseudovirus) to support late-stage development and commercialization efforts for our company.A Typical Day in the Role Might Look...
Regulatory Affairs Associate
2 months ago
Regulatory Affairs Associate (Tarrytown, NY)Department:
Science & Technology
Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.
JOB SUMMARY:
The Regulatory Associate will report to the Senior Manager, Regulatory Affairs and, under the direction and guidance of the Associate Vice President, will help to ensure regulatory compliance of Prestige marketed products. Product categories include OTC Monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements and EPA-registered products. The individual must be data driven/analytical and able to develop and maintain effective working relationships with external suppliers and internal team members.
MAJOR RESPONSIBILITES/ACTIVIES:
Seeking a skilled Associate to perform these responsibilities including, but not limited to:
- Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as intelligence, compliance, local, state and federal regulations (FDA, HC and EPA)
- Product and Facility listing registration (e.g., drug, medical device, cosmetic, packaging (GUDID))
- SDS (Safety Data Sheet) compilation and maintenance
- State license maintenance (e.g., pharmacy, wholesale, manufacturing licenses)
- Regulatory documentation and record-keeping
- Maintenance of regulatory databases and systems
- Stay up to date with changing regulations and guidance documents
- Prepare and review regulatory documents (e.g., labels, packaging, advertising)
- Review product labeling for regulatory accuracy
- Assist with regulatory affairs projects and initiatives as needed, including support for regulatory submissions (e.g., 510(k), APRs, PSURs)
- Provide regulatory guidance and training to internal teams
- Provide cross-functional support to groups including Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing as directed by the Sr. Manager, Regulatory Affairs.
REQUIREMENTS:
- Bachelor's degree in a scientific field (e.g., biology, chemistry, pharmacy)
- Knowledge of FDA regulations and guidance (e.g., CFR, ISO, CPSC, DHEA regulations)
- Strong organization, written and oral communication skills, and perform tasks with accuracy and a high attention to detail.
- Ability to work in a fast-paced environment and prioritize tasks
- Demonstrated experience with Microsoft Office Suite
- Must be able to work in Tarrytown, NY in a hybrid schedule (3 days in office – Tuesday, Wednesday, Thursday, and 2 days remote – Monday, Friday)
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
REASONING ABILITY:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Powered by JazzHR
ucj4V8UTaI