Search Results: 2,895 vacancies
...Responsibilities:
Provides administrative support for regulatory affairs manager
Provides RA support for change control projects... ...need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA...
Suggested
Worldwide
...health in the future.
Objectives/Purpose of Job:
* The Regulatory Affairs Senior Specialist handles US regulatory development aspects... ...with country-specific regulatory affairs personnel for international submissions and registrations.
* Occasional travel may be...
Suggested
Work visa
...ensuring the pieces are in compliance with all applicable laws, regulations, and regulatory agency guidance.
**KEY ACTIVITIES/RESPONSIBILITIES:**
+ Manages or represents Regulatory Affairs on the promotional review committees for prescription products to review...
Suggested
Holiday work
Temporary work
Flexible hours
...Leadership responsibility for global regulatory strategy to support the development of biomarkers... ...and provide input and updates within internal cross-functional teams (e.g., Diagnostic... ...including experience within Regulatory Affairs
+ Understanding of scientific content...
Suggested
Local area
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Lead for a prominent Pharmaceutical client of ours. This position is in Bridgewater, NJ (Hybrid Role). Details for the position are as follows:
Job Description:
~...
Suggested
Flexible hours
...partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development... ...pharmaceutical industry required.
~8 or More Years in regulatory affairs
~ Experience in providing regulatory strategic input into...
Suggested
...regulations.
Responsibilities:
* Provides regulatory review and approval of advertising and... ...and promotional material to meet internal timelines and requirements.
* Monitors... ....
* Works closely with the Regulatory Affairs labeling group in order to assess and determine...
Suggested
Holiday work
Fixed term contract
Remote job
Work visa
...~10+ years' experience in Global Regulatory affairs, CMC submissions.
~ Knowledge on Insights and regulatory affairs.
~ Develop the detailed project plan
~ Kickoff the project with full project team including IT, Validation and Business participants...
Suggested
...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration... ...authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations...
Suggested
Contract work
Shift work
Day shift
...The CMC Regulatory Affairs Specialist is responsible for for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.
Essential Duties and Responsibilities include, but are not limited to,...
Suggested
Temporary work
Local area
...in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The...
Suggested
Work experience placement
...Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension)position... ...teams to assist with the coordination and completion of international regulatory documents. This role will give you an opportunity...
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Holiday work
Contract work
Temporary work
Local area
...Responsible for leading and developing global regulatory strategy for assigned development... ...Represents Daiichi Sankyo's regulatory group in internal and external development project... ...5 years of experience within Regulatory Affairs
~ Knowledge of IND, NDA/BLA submission...
Suggested
...Regulatory Affairs Specialist II (Clinical)
Bridgewater, NJ-100% Remote
7 Months contract
Pay Rate: $45-55/hr on w2
Candidates can... ...both written and verbal, with the ability to collaborate with internal employees. Top must-have skills: •3 - 6 Years; US-specific...
Suggested
Contract work
Remote job
...Associate Director, Regulatory Affairs
Position Summary:
Catalent is a global, high-growth, public company, and a leading partner... ...advance
Upwards to 20% travel expectations (domestic & international)
Other duties as assigned
The Candidate:
~ Bachelor...
Suggested
Holiday work
Full time
Local area
Worldwide
...This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems...
...Responsibilities:
Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company... ...mentorship, and development opportunities for the regulatory affairs and quality assurance teams.
Qualifications:
Bachelors degree...
...Responsibilities:
Excellent employment opportunity for a Regulatory Affairs Consultant in the Somerville, NJ area.
Represent... ...II and III devices
~ Experience with complaint handling, international registration and 510k submission
~ Development of international...
Contract work
...Sr. Manager, Global Medical and Regulatory Affairs Management Services
Our client, a well-established international diagnostics company, is searching for someone to oversee both the financial operations (planning & control) and outsource management (vendor & contract...
Contract work
For contractors
2 days per week
3 days per week
...materials, and help develop and implement regulatory strategies for promotion and advertising... ....
Provides guidance and feedback to internal Sanofi constituencies (commercial groups... ...or medical device Regulatory Affairs.
Successful track record with ideally...
Work experience placement
