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Regulatory Affairs Analyst Jobs

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 Fda Consultant
By Arcondis Group At Texas, United States
Proficiency in project management and ability to handle multiple projects simultaneously.
In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.
Excellent written and verbal communication skills.
Serve as the main liaison between clients and FDA, facilitating effective communication and swift resolution of issues.
Keep abreast of changes in FDA regulatory guidelines, standards, and policies, interpreting their implications for client projects.
Advise clients on the clinical data necessary to support device and drug approval, including the design and review of clinical studies.
Research & Regulatory Analyst Jobs
By GreenLite Technologies At Texas, United States
Strong organizational skills and extreme attention to detail
Demonstrated ability to manage priorities and projects in a dynamic, fast-paced environment
Working closely with the Head of Research & Regulatory on any ad-hoc, or internal research/regulatory requests or projects.
Ability to read, analyze and translate/summarize government and legal code/statutes - including Building Code, Land Use/Zoning, Development Ordinances, Code Enforcement Policies
Initiative and bias for action, on-time delivery, and operational excellence
Honest and direct without any ego
Sr Regulatory Analyst Jobs
By Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma & Texas At Chicago, IL, United States
Bachelor degree and 3 years health insurance/managed care industry experience OR 7 years health insurance/ managed care industry experience.
2 years regulatory experience analyzing legislation/regulations
Experience working on cross functional teams.
Knowledge of the regulatory process and industry business processes.
Experience interpreting state and federal regulations, identifying impact and recommending appropriate business solutions
Clear and concise verbal and written communication skills.
Regulatory Affairs And Documentation Officer
By Lallemand At Milwaukee, WI, United States
Work with Plant Manager and Marketing to print packaging, including coordination of files and proofs with printers.
Knowledge of IT tools (Excel, Word, SharePoint)
Coordinate with global Documentation and QA teams to ensure consistency in documentation and processes between the Americas and other regions.
Complete documentation requests from customers.
Submit and maintain product registrations at State level in the United States.
Complete state tonnage reporting, small package and license renewals on appropriate intervals.
Regulatory Affairs Associate Jobs
By Inari At West Lafayette, IN, United States
Track and manage documentation for the Regulatory Project Plans including agency consultation,
Support variety registration when applicable and verify data needs and generation. Manage filing
Support Regulatory Intelligence activities and tracking evolution of data requirements and
Monitor Regulatory competitor activities and access to information where available. Manage the
Solid experience in biological sciences, preferably agricultural sciences, or related disciplines;
3-5 years of work experience in agricultural or microbial biotechnology
Regulatory Affairs Associate Jobs
By CellCarta At Naperville, IL, United States
Detail-oriented with good organization and time management skills.
Make decisions related to work processes or operational plans and schedules in order to achieve program objectives established by senior management.
Develops regulatory processes and procedures aligned with global regulatory requirements and train key personnel in accordance with these processes and procedures.
Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements.
Utilize technical regulatory skills to propose strategies on complex issues.
Determine submission and approval requirements.
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
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 Operations Analyst Jobs
By Airbnb At San Francisco, CA, 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 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 .
Research Director/Regulatory Affairs Mngr
By Napa Research Center At Pompano Beach, FL, United States

Opportunity to advance career in clinical research company. Great financial compensation plan with healthcare benefits. Overlook responsibility of a great dedicated staff and be an integral part in ...

Regulatory Affairs Associate Jobs
By Intellectt Inc At Alameda County, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Typically reports to a manager or head of a unit/department.
knowledge of FDA PMA guidance documents and CFR regulations.
Regulatory Affairs Associate Jobs
By Mindlance At Plano, TX, United States
Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)
Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.
Review regulatory documents to assure FDA requirements are met and are ready for submission
With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.
Needs to be able to organize and prioritize tasks and work independent of manager.
With more complex tasks/submissions, work with the manager to accomplish goals/tasks.
Regulatory Affairs/Compliance Assistant
By CitiStaffing At New York City Metropolitan Area, United States

Provide administrative support to the COO/Head of Trading Surveillance, Regulatory Affairs & Compliance.

Director- Iso Regulatory Affairs
By Jupiter Power At Austin, TX, United States
5-7 years of experience in regulatory affairs, policy, trade compliance, strategy or business development in the power market industry
Experience in PJM, MISO or NYISO power markets
Experience in managing external consultants and deriving/approving external scopes of work
Experience representing power generation in ISO/RTOs
Extensive work experience beyond the 5-year minimum.
Lead ISO/RTO Regulatory Affairs Activities for FERC jurisdictional electricity markets, including formulation of internal policy goals and external representation
Chief Of Regulatory Affairs
By Idea Evolver At Philadelphia, PA, United States
10+ years of experience in Regulatory and Quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs.
Overseeing QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements.
Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level.
Experience working with medium to large-sized businesses in a client-facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.
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)

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