Average salary: $92,462 /yearly
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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri
Pay Rate starts: $47/ HOUR
HM Notes:
~ Hybrid - onsite Tuesday & Thursday - This can change at any time....
Regulatory
Contract work
Shift work
Day shift
...Working with the team on regulatory and licensing matters relating primarily to insurance and reinsurance filings with North American regulatory agencies. Research and analysis on various insurance laws and regulations as well as privacy, data protec Regulatory, Legal...
Regulatory
...Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP) and Institutional...
Regulatory
Local area
...Responsibilities:
Provides administrative support for regulatory affairs manager
Provides RA support for change control projects and sustaining activities
Conducts regulatory assessments and determines need for re-registration for proposed device changes...
Regulatory
Worldwide
...proprietary system will quickly have you in front of a live recruiter.
The Opportunity
Description
We're looking for a Regulatory Affairs Specialist III , working in Pharmaceuticals and Medical Products industry in Bridgewater, New Jersey, United States...
Regulatory
...cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation...
Regulatory
...well as other research areas centered around rare diseases and immune disorders.
Summary
Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our...
Regulatory
Local area
...novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving...
Regulatory
...Summary
This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing...
Regulatory
Contract work
...~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...
Regulatory
...Description:
The Associate II assists with minimal guidance, the Director of Specialty Regulatory Affairs with all IND/NDA related activities.
Essential Functions:
+ Compilation of regulatory submissions including INDs, NDAs, amendments and supplements and manage...
Regulatory
...Responsibilities
About the job
Our Team:
The team is involved in developing and executing regulatory strategies for rabies vaccines in post marketing and in development stages to support the Traveler Endemic Franchise business, driving the growth of the Vaccines...
Regulatory
Worldwide
•Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
•Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
•Ensure...
Regulatory
3 days per week
...direction of the Vice President and Assistant Vice President, the Director takes an active role in facilitating and coordinating regulatory activity for the enterprise and its facilities. The Director will develop and sustain professional relationships and work processes...
Regulatory
Temporary work
Work experience placement
Local area
Flexible hours
...facilities and through strategic partnerships with manufactures from around the world.
JOB SUMMARY:
The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. A Senior Associate is expected to have...
Regulatory
Overseas
...Job Description
Job Description Come Join Our Growing Team!
We are looking for a Senior Director - Regulatory Affairs to join our US team. This role is responsible for planning, directing and coordinating regulatory submission activities for sponsors to ensure...
Regulatory
Contract work
...on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director of Regional Regulatory Vaccines Lead? The job is located in the Summit NJ or King of Prussia office. This is a hybrid position. You will report to the...
Regulatory
Summer work
Worldwide
...Accurately implement all relevant information that must appear on a specific SFP utilizing the correct SFP format according to regulatory guidelines.
Facilitate the interdepartmental and customer (when applicable) approval of a draft SFP to ensure that a Purchase...
Regulatory
Contract work
...Beauty is part of the LVMH Group.
Job Description
POSITION OVERVIEW
For the LVMH Beauty scope of brands, joining the Regulatory Affairs & External Relations team to lead the operational regulatory affairs team on cosmetics and OTC drugs. This role will be...
Regulatory
Full time
Flexible hours
...research areas centered around rare diseases and immune disorders.
Summary
The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading all planning activities for Daiichi Sankyo major submissions...
Regulatory