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Regulatory Affairs Coordinator Jobs

Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
Regulatory Affairs Lead Jobs
By Bramwith Consulting At Massachusetts, United States
Ensure sustained quality and efficiency through modern artwork management systems
Extensive experience working with Healthcare/Pharmaceutical product labelling
Consistently drive continuous improvement related to global Pharmaceutical labelling
Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices
Strong understanding of Pharmaceutical Regulatory Bodies across a global remit
Degree from a leading college
Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Irb Regulatory Coordinator Ii
By Fred Hutch At Seattle, WA, United States
Excellent time management skills and meet deadlines
Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System.
Previous experience working with online/web-based platforms for clinical trial management systems
Manage the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.).
A minimum two years of regulatory, human research protection or related experience in a research environment.
Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.
Regulatory Affairs, Noram Jobs
By Biocon Biologics At New Jersey, United States
Minimum 12 years relevant experience out of which more than 5 years of people manager role
Responsible for Noram regulatory strategy of both products approved and products under development.
Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.
Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
Assist North America head on product development strategy and participate in building the regulatory strategy.
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion At , $28 an hour
Experience with vendor and supplier management and engagement
Experience with contract management systems for legal agreements and contracts
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.
Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations
A minimum of 3 years' experience in clinical regulatory affairs highly preferred.
Regulatory Affairs Consultant - Usa Remote
By Alien Technology Transfer At ,
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Regulatory Affairs Professional Jobs
By Sartorius At , Remote
Deep knowledge of the relevant Regulatory requirements
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
8+ years relevant experience within the Regulatory Affairs discipline
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
Proven analytical skill and technical/scientific competence.
Strong initiation and organizational skills
Regulatory Affairs Complaint Investigator (Fda)
By ZOLL LifeVest At , Pittsburgh, 15238
Experience with Microsoft Access Preferred
Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.
Location: Remote, PA, United States of America
Liaise with the distributor, service, and engineering departments in acquiring relevant information for complaint investigations.
Compile complaint investigation information for final RAE review and approval.
Provide administrative support during product recall notifications, advisory reports, and incident reports.
Regulatory Coordinator Jobs
By University of Washington At Seattle, WA, United States
Knowledge of Clinical Trial Management Systems (CTMS) such as OnCore
Knowledge of regulatory and administrative requirements of clinical research and translational research projects.
Knowledge of IRB submission procedures, FDA and NIH requirements relating to research involving human subjects.
Knowledge of regulatory requirements associated with Exempt From Informed Consent (EFIC) trials and Public Health Surveillance projects
Strong organization, communication, and interpersonal skills to work effectively with study sponsors, investigators, and research personnel involved in research projects.
Translate complicated research protocol requirements into language easily understandable by research participants.
Regulatory Affairs Leader Jobs
By GE HealthCare At Chicago, IL, United States
Professional experience in regulatory project management/program management and regulatory agency interactions.
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
Professional experience in Regulatory Affairs / Quality Assurance.
Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.
Regulatory Affairs Scientist – Nutritional Supplements
By Wellington Executive Search At Denver, CO, United States
Communicate to the Operations Manager, Director of Quality, or other Senior Management as appropriate any potential issue.
An experienced formulation and applications team
Prior experience working with documentation pertaining to nutritional supplements and ingredients
Good analytical problem-solving skills. Meticulous with follow-up
Good communication skills. Able to give clear directions to others.
Quality Assurance, Compliance, Labelling, Documentation, and Regulatory Requirements
Regulatory Coordinator Ii Jobs
By Fred Hutch At Seattle, WA, United States
Strong organizational and document management skills.
Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
Bachelor’s Degree in a health related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience required.
A minimum of 3 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function required.
Experience using central and local IRBs.
Ability to interpret and apply local, state, and federal requirements.
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.
Global Clinical & Regulatory Affairs Coordinator
By Omni Inclusive At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
Regulatory Coordinator Jobs
By Pace® Analytical Services At Greater Minneapolis-St. Paul Area, United States
Pre-existing knowledge of the subject is not mandatory
Experience with databases, Excel, and other spreadsheets
Strong verbal and written communication skills
Comprehensive benefit program, including medical, vision and dental insurance, 401(k) matching and a tuition reimbursement program
Create and maintain training for team procedures and best practices as procedures change
Assist with team daily Scrum meetings to ensure that the projects run smoothly

Are you looking for an exciting opportunity to join a dynamic team in Regulatory Affairs? We are looking for a Regulatory Affairs Coordinator to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching, preparing, and submitting regulatory documents, tracking regulatory submissions, and providing regulatory support for our products. If you have a passion for regulatory affairs and are looking for a rewarding career, this could be the perfect job for you!

Overview Regulatory Affairs Coordinators are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with government agencies, industry organizations, and other stakeholders to ensure that the company’s products and services are in compliance with all applicable regulations. Detailed Job Description Regulatory Affairs Coordinators are responsible for researching, interpreting, and implementing applicable laws and regulations. They must be knowledgeable about the relevant laws and regulations and be able to effectively communicate them to other stakeholders. They must also be able to develop and maintain relationships with government agencies and industry organizations. Regulatory Affairs Coordinators must also be able to identify potential areas of non-compliance and develop strategies to address them. Regulatory Affairs Coordinators must also be able to develop and maintain internal policies and procedures to ensure compliance with applicable laws and regulations. They must be able to monitor changes in the regulatory environment and ensure that the company’s products and services remain in compliance. Regulatory Affairs Coordinators must also be able to provide guidance and advice to other departments within the company regarding compliance issues. Skill Requirements Regulatory Affairs Coordinators must have excellent communication and interpersonal skills. They must be able to effectively communicate with government agencies, industry organizations, and other stakeholders. They must also be able to effectively interpret and explain applicable laws and regulations. Regulatory Affairs Coordinators must also have strong research and analytical skills. Qualifications Regulatory Affairs Coordinators typically have a bachelor’s degree in a related field such as business, law, or public policy. They may also have experience in a related field such as compliance, legal, or regulatory affairs. Knowledge Regulatory Affairs Coordinators must have a thorough understanding of applicable laws and regulations. They must also have a strong understanding of the regulatory environment and be able to identify potential areas of non-compliance. Experience Regulatory Affairs Coordinators typically have at least two years of experience in a related field. They may also have experience working with government agencies and industry organizations. Responsibilities Regulatory Affairs Coordinators are responsible for researching, interpreting, and implementing applicable laws and regulations. They must be able to develop and maintain relationships with government agencies and industry organizations. Regulatory Affairs Coordinators must also be able to identify potential areas of non-compliance and develop strategies to address them. They must also be able to develop and maintain internal