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Regulatory Affairs Analyst Jobs in Mississippi, Arkansas

Regulatory Analyst Jobs
By Medix™ At Mississippi, United States
Two (2) years of clinical research regulatory, professional or related experience, one (1) year if bachelor’s degree.
2 Years of Regulatory Experience
CTEP / CTSU / NCI CIRB experience would be very helpful
Start up and ability to grow
The work will take you from the lab to the office to the board room.
Must demonstrate the ability to meet deadlines.
Quality And Regulatory Affairs Analyst - Genetics Clinical Trials
By Mount Sinai Health System At United States
Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research
2+ years of experience in clinical research
Experience using electronic regulatory platforms a plus
Experience with industry-sponsored clinical trials preferred
Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations
Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits
Regulatory Affairs - Chemistry Manufacturing Controls (Cmc)
By Keasis At United States
· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
· Knowledge ofregulatoryguidelines and relevant applications.
· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !
Qualifications we seek in you!
• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields
Regulatory Affairs Consultant Jobs
By Life Science People At United States
Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions
Experience with leading cross-functional teams
As the roles can range, it would be ideal to have experience with the following:
5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)
May require up to 10% travel
This would be a contract role, and they are open to either full-time or part-time capacity.
Regulatory Affairs Liaison Jobs
By EPM Scientific At United States
In-depth knowledge of relevant national and international regulatory requirements, guidelines, and standards, such as FDA, EMA, ISO, etc.
Proficient in using regulatory databases, document management systems, and other relevant software tools.
Familiarity with quality management systems (QMS) and regulatory compliance auditing is a plus.
Coordinate and manage regulatory submissions, including applications, registrations, notifications, and reports, ensuring completeness, accuracy, and adherence to specified timelines.
Conduct thorough research and analysis of regulatory requirements, guidelines, and industry best practices as needed – to ensure regulatory compliance.
Keep abreast of changes in regulatory requirements and communicate updates and potential impacts to relevant departments within the organization.
Regulatory Affairs Cmc Jobs
By SAGE IT At United States
•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication
Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)
•Manage post approval changes where needed
Qualifications we seek in you!
•Prior experience in big (or mid-size) Pharma companies
•Robust communication and presentation skills
Regulatory Affairs Associate Jobs
By Hilco Vision At United States
Possible expansion to assist with pre-market management of one or more product lines
You have a BS degree with 0 - 2 years of experience working with Regulatory and Compliance data
You have strong computer skills, including the MS Office suite, and have an aptitude to learn M3, or other ERP systems
You have a strong commitment to integrity, ethical business conduct, and legal compliance.
You’re familiar with researching legislation and regulatory guidance
You’re adept at managing sensitive and confidential information, and are able to balance multiple priorities and assignments when needed
Regulatory Analyst Jobs
By Tailored Management At United States
Previous project management experience is a plus.
2 - 4 years’ experience in investigations and resolutions in a related industry or college degree
Excellent investigation skills and extreme attention to details
Experience working and coordinating efforts with multiple stakeholders
Quick learner, operates with urgency and curiosity, and evolves your knowledge as new information becomes available
Strong verbal and written communication skills
Regulatory Operations Analyst Jobs
By Cypress HCM At United States
· Previous project management experience is a plus
· 2 - 4 years experience in investigations and resolutions in a related industry or college degree
· Excellent investigation skills and extreme attention to details
· Experience working and coordinating efforts with multiple stakeholders
· Quick learner, operates with urgency and curiosity, and evolves your knowledge as new information becomes available
· Strong verbal and written communication skills
Associate Director Regulatory Affairs
By GQR Global Markets At United States
Manage submission plans and timelines to ensure approvals are timely and development objectives are met .
Manage regulatory data and information within systems .
Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Represent and coordinate regulatory information as a team member, covering clinical, non-clinical, CMC, labeling, and post-approval change activities .
Assistant Regulatory Analyst Jobs
By FoodChain ID At United States
0- 2 years professional work experience
Education or backgrounds that are most suitable are in international relations, political science, food safety or some science
Experience compiling, organizing, and managing information in spreadsheets or databases
Monitoring for international regulatory updates from multiple online sources
Analyzing international food safety regulations and proposals
Entering regulatory information into the data capture system (CERES)
Director, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Regulatory Affairs Associate (Consumer Products)
By The Fountain Group At United States
Rate $40-45 an hour depending on experience.
100% remote – CST hours preferred.
A bachelor’s degree in a life science discipline and 3+ years of relevant regulatory experience, including FDA and Health Canada regulations.
Regulatory experiences on Class I Medical Device or Consumer Products or Cosmetic Products.
Provide regulatory support on Labeling and Ad Promo (Artwork/copy doc.) reviews and approvals.
Provide regulatory support with procedures/SOP development and continuous improvements.
Regulatory Affairs Associate Ii
By Integrated Resources, Inc ( IRI ) At United States
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• Manage the application and communication of all *** policies, procedures, and *** Way of Management.
• Effective personal time management.
LOCATION: Can be 100% Remote (or Hybrid/Plainsboro, NJ)
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER
Cmc Regulatory Affairs Jobs
By Skills Alliance At United States
Proven regulatory project management expertise – coordinating and managing submissions activities across multiple projects (E);
Provides strategic and technical input on regulatory requirements to support authoring of BLA Module 3 sections and executes the strategy
Experience in CMC biologic drug development (E); experience in cell and gene therapies development (P);
Good working knowledge of FDA and EU CMC regulations and guidelines related to cell and gene therapies (P);
Experience with environmental risk assessments/GMO submissions for gene therapy products internationally (P);
Strong communication skills and the ability to work collaboratively (E);
Ivdr Regulatory Affairs Specialist Ii
By Zing Recruiting At United States
Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
Bachelor’s degree (Master’s degree is a plus) with a minimum of 5 years of experience in a regulated industry.
Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
Experience with IVD PMA submissions preferred.
Summary of responsibilities for this Regulatory Affairs Specialist II
Vice President Of Regulatory Affairs
By Barrington James At United States
Experience in the full-life cycle management of Regulatory submissions (small molecule)
12+ years experience in Regulatory Affairs
Experience with commercial launch of a product and in leading commercial stage product regulatory activities
Experience in a small or start-up organization (preferred)
Experience managing and collaborating with outside partners/vendors (preferred)
Vice President of Regulatory Affairs - Remote
Sr Regulatory Affairs Consultant
By Mittal Consulting LLC At United States
Manage multiple, parallel projects to successful completion
Experience with PMAs is required
Client centered focus and problem solving skills
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Minimum 5 years of related regulatory experience, including:
Senior Director Regulatory Affairs
By Tigermed At United States
Have full knowledge of regulations in US FDA.
Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
Ability to independently manage and monitor multiple projects without direct supervision.
To participate or lead regulatory project related to US FDA filing.
Contribute to the development of regulatory strategy for specific projects, including identifying and assessing regulatory risks.
Responsible for establishing and maintenance of standard operation procedure and other related working standard for US FDA filing.
Regulatory Affairs Specialist - Cmc
By Integrated Resources, Inc ( IRI ) At United States
: Technical Writing and Document Management
Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, GRS CMC, management).
This is a fully remote role
Manage dossier content and agency questions delivery timelines aligned with global CMC submission timelines.
-Bachelors degree or equivalent in relevant discipline with a minimum of 2 years experience
-Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred.

Are you looking for a challenging and rewarding career in Regulatory Affairs? We are looking for a Regulatory Affairs Analyst to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory requirements, preparing regulatory submissions, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for an opportunity to make a difference, this could be the perfect job for you!

A Regulatory Affairs Analyst is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for researching, interpreting, and communicating regulatory requirements to internal stakeholders, as well as providing guidance on regulatory compliance.

What is Regulatory Affairs Analyst Job Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office Suite

What is Regulatory Affairs Analyst Job Qualifications?

• Bachelor’s degree in a related field such as law, public policy, or business
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (e.g. Regulatory Affairs Professional Society (RAPS) certification)

What is Regulatory Affairs Analyst Job Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment and its impact on business operations
• Knowledge of the product development process
• Knowledge of the regulatory submission process

What is Regulatory Affairs Analyst Job Experience?

• Previous experience in regulatory affairs
• Experience in a related field such as law, public policy, or business

What is Regulatory Affairs Analyst Job Responsibilities?

• Research and interpret applicable laws and regulations
• Develop and maintain regulatory compliance strategies
• Prepare and submit regulatory documents
• Monitor regulatory changes and updates
• Provide guidance and advice on regulatory compliance
• Liaise with internal and external stakeholders
• Track and report on regulatory compliance activities