Average salary: $40,160 /yearly
More stats ...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
...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
...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
...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
...What You'll Do:
# Collects and records patient care data that follows format and guidelines of the patient care service, regulatory agencies and third-party payers which reflects an understanding of reimbursement systems and their impact on patient care.
# This...
Regulatory
Full time
Relocation bonus
...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
...resident care and services regulations
Resident Rights
Resident Assessment/Evaluation process in accordance to state / province regulatory requirements
Qualifications:
Graduate of approved college / school of nursing.
Maintains a current state license as...
Regulatory
Full time
Local area
Flexible hours
Weekend work
Afternoon shift
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...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
...outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's requirements....
Regulatory
Contract work
For contractors
Worldwide
...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
...Responsibilities
At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.
Provide statistical support to Clinical Development Plan for multiple compounds
Participate in pre-IND and...
Regulatory
Remote job
Internship
...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
...Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop PK-PD concepts and analysis, phase 1-4...
Regulatory
...generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation...
Regulatory
For contractors
...typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission...
Regulatory
...Experience in global clinical trial operations including experience developing protocols and key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
Effective project management skills, cross-functional team leadership and organizational skills
To be...
Regulatory
Local area
3 days per week
...but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework...
Regulatory
...and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology...
Regulatory
...established metrics and identifying potential new metrics
Supporting continuous improvement projects assigned potentially within regulatory compliance, internal/supplier auditing, or customer focus activities
Performing the necessary daily responsibilities in...
Regulatory
Full time
Part time
Internship
Local area
...disbursement accounts, payroll, customer accounts, and other financial accounts
Ensure compliance with GAAP regulations and other regulatory frameworks and internal policies and procedures
Maintain knowledge of acceptable accounting practices and procedures...
Regulatory
Holiday work
Full time
Overseas
Flexible hours
...we make daily life safer, cleaner, healthier and greener . If you like making a difference, we are the company for you!
The Regulatory Affairs Specialist role involves the provision of a high level of regulatory expertise and guidance to the Arxada Industrial Microbial...
Regulatory
...and our shareholders. In this role, you will be:
Learning complex business processes and assessing the full range of Financial, Regulatory, Operational, Strategic and Technology risks.
Designing and executing integrated audit programs that target high-risk areas in...
Regulatory
Full time
Work experience placement
Work from home
Home office
...toward a sustainable, clean energy future through our subsidiary, Suburban Renewables!
We have an exciting opportunity for a Regulatory Compliance Manager Renewable Natural Gas (RNG), who will be responsible for developing, maintaining, and enforcing company compliance...
Regulatory
Temporary work
Local area
Immediate start
...consumer benefits. TRI-K Industries is a wonderful place to start your career with opportunities to learn and grow.
Summary: Regulatory & Sustainability Expert/Specialist role manages regulatory and sustainability projects. Provides training, prepares presentations...
Regulatory
Work experience placement
Local area
...data
This position may review and approve safety documents
Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active...
Regulatory
Work experience placement
Local area
...colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.
This role might be for you if...
Regulatory
Interim role
Local area
...all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all clinical & companion...
Regulatory
Contract work
Work experience placement
...around rare diseases and immune disorders.
Summary
The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small molecule and biological drug products consistent...
Regulatory
Overview:
The Senior Director, Regulatory Affairs- GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance...
Regulatory
Local area
...content development with Figure 1/freelance writers and translators, managing agency and client input, and shepherding content through regulatory approvals.
Plan and lead client meetings, develop presentations and other supporting materials as required, prepare, and...
Regulatory
Permanent employment
Full time
Freelance
Remote job
Worldwide
