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What You'll Do :
As the Manager, Regulatory Operations and Submissions Management, this position will lead regulatory operations activities and support and manage US and...
Suggested
Full time
Remote job
Worldwide
Flexible hours
...extend the life of vital infrastructure while working to reduce our and our customers' ecological footprint.
Arxada seeks a Regulatory Manager to champion regulatory excellence. You'll be a technical leader ensuring compliance across Arxada's product portfolio. This role...
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...Manage Lupin's existing REMS programs and help in the development of new REMS programs (as needed) with the support... ...patient safety programs. Works closely with Phar Regulatory Affairs, Manager, Regulatory, Operations, Product Development, Skills, Business Services...
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The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global... ...to cross-functional teams.
Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness...
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Work experience placement
Worldwide
...around rare diseases and immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA... ...stakeholders (e.g., RA CMC, R&D Excellence, Clinical Operations, IT).
Responsibilities Operate within and in support of...
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...around rare diseases and immune disorders.
Summary
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides... ...group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement...
Suggested
Work experience placement
...monitoring and surveillance of changes in the regulatory landscape focused on drug development... ...a typical day might include:
Project Management and leadership in the delivery of... ...intelligence in support of a range of operational study design and operational planning activities...
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Local area
Relocation package
PwC
PLS Regulatory Senior Manager
Florham Park ,
New Jersey
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Specialty/Competency:
Conduct and Compliance
Industry/Sector:
Pharma and Life Sciences
Time Type:
Full time
Travel Requirements:
Up to 40%
A career within Regulatory Risk and Compliance services...
Suggested
Full time
H1b
...ROLE AND RESPONSIBILITIES:
Manage Lupins existing REMS programs and help in... ...closely with Pharmacovigilance, Commercial Operations, Finance and Legal in the development... ...Responsible for maintaining and updating various regulatory databases to ensure accuracy of...
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...The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory... ...unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired...
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Local area
...This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting... ...and submit regulatory filing documents, manage documentation systems and maintain... ..., planner, and implementer.
Ability to operate independently with minimal supervision....
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Contract work
...Job Description
Job Description Job Title: Regulatory Operations Specialists
Job Location: Rahway, NJ
Job Duration: 12+ Months... ...procedures, processes, and infrastructure; and assist with document management and archiving as necessary.
The specialist provides...
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Remote job
Shift work
...communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including... ...regulatory strategies for in-line products through life cycle management programs.
Contribute A&P expertise to the development of...
Suggested
Work experience placement
...Summary
The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading... ..., etc. are raised on dossier planning/submission topics.
Manages and develops internal talent ensuring a balance between...
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Management Expert
Contribute to the development of PSRs, when applicable, with the support... ...update the local quality documents
PV Regulatory Intelligence
Ensure appropriate... ...Safety Heads
Regional PV Heads
Global PV Operations Team
Global Medical Safety Team
QPPV Office...
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Local area
Remote job
...in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Experience with sterile products preferred.
Location... ...CMC change controls with supervision.
4. Responsible for the management of CMC activities related to developmental or commercial...
...Immediate need for a talented Regulatory Operations Specialists - II (Associate) . This is a 12+ Months contract opportunity with long-term potential and is located in Rahway, NJ (Onsite) . Please review the job description below and contact me ASAP if you are...
Contract work
Immediate start
...Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.
The Manager, Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions. In addition, this individual...
Holiday work
Temporary work
Flexible hours
...:
We are seeking a life-sciences professional with healthcare regulatory experience to serve as the Director of Regulatory Affairs within... ...The Director of Regulatory Affairs plays a vital role in the management of clients, billable projects, and staff. This position is...
Holiday work
Temporary work
Work experience placement
Flexible hours
...Job Description
Job Description Lawyer.com is looking for a passionate and hardworking Product and Operations Manager to join our team!
Lawyer.com, Inc. is a leading online service provider to lawyers and consumers. We manage a leading database of over 2 million...
Summer work
Work visa
