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Regulatory Operations Specialist Jobs

Regulatory Operations Specialist Jobs
By Jobot At San Diego, CA, United States
Incredible company culture and proven management team
MS WORD knowledge with WORD styles to format various documents for regulatory submissions
ECTD publishing experience with using eCTD software to produce a compliant electronic submission
3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)
QC experience is a plus
REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech
Regulatory Specialist Jobs
By nutpods At Bellevue, WA, United States
Base salary range of $65,000 to $85,000 per year, depending on education, experience, knowledge, skills, and abilities
Maintain accurate, operational, and functional quality databases related to product specifications and regulatory Information, including label management
Support packaging quality control and management
Manage 3rd party certifications for products
Manage relevant QA programs as assigned
Manage document and version control for operations related documents and programs
Regulatory Specialist, Fragrance & Beauty
By CHANEL At Piscataway, NJ, United States
Section 5: What skills you will learn? What experiences might you have?
Trained and acting in-person coverage for quality assurance (QA) personnel, as well as helping manage QA union inspectors when needed
Minimum Education: B.S. Chemistry or related science
Minimum Years of Experience: 1-3 years of Cosmetic or related industry experience
Special Requirements of the Position: French speaking a plus
Communication skills (both internal and external)
Regulatory Specialist (Open To Remote) ($81000.00 - $115000.00 / Year)
By Talentify.io At United States
Experience in clinical research management and oversight, including project management in a dynamic research setting.
Knowledge, Skills And Abilities (required)
Experience in developing and implementing training/education.
May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for projectteams.
Strong knowledge of REDCap system
Experience working with OnCore system
Senior Regulatory Specialist Jobs
By Cerberus Capital Management At New York, NY, United States
Must have intermediate to advanced excel skills; macro experience is preferred
Research new regulatory developments and reporting requirements
Must be analytical, detail oriented and have excellent communication skills
Experience with Accounting preferred but not required
Analyze the various data components within our SAP Business Objects proprietary Datawarehouse
Prepare regulatory filings with multiple government agencies including Form PF, Form SLT, Form Tic-B, Form PQR, Canadian filings, Annex IV
Regulatory Data Specialist Jobs
By FEFA, LLC At Fairfax, VA, United States
Experience performing data entry functions a must
Work closely with the production managers to ensure and document standard operating procedures that support data quality and production efficiency
A high school diploma (an Associate degree is preferred) with a minimum of two years of related experience.
Understand transcribing procedures and relevant state-of-the-art data entry/computer equipment.
Apply regulatory standards and prepare data for output to a variety of printed and electronic media
Maintain accurate and up-to-date documentation of project details
Rn Accreditation & Regulatory Specialist
By St. Francis-Emory Healthcare At , Columbus, 31904, Ga
Maintains current knowledge of regulatory/accreditation requirements and best practice strategies and serves as an expert resource for clinical and medical staff.
Facilitates and communicates regulatory requirements and changes, hospital policies and procedures and safety guidelines.
Researches and implements new information technology for meeting data requirements and continuous quality improvement standards.
Attends all required quality/safety training programs and can describe his/her responsibilities related to general safety, department/service safety, job specific related hazards.
Provides disease specific screenings and provides education and support within the community.
Prepares and updates patient education materials as needed.
Regulatory Specialist Jobs
By iLocatum At Greater Houston, United States
10-15 years experience in Regulatory within offshore pipelines, preferably OCS
Must be ok with working in an in-office setting
Can work with minimal supervision
Must be US Citizen / US Perm Resident
Must be within a commutable distance
OCS GOM shelf permitting / pipeline permitting
Senior Regulatory Specialist Jobs
By Compliance Group Inc At Greater Columbus Area, United States
Applies regulatory and technical knowledge to a wide variety of complex work assignments.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
Knowledge of regulations and standards affecting IVDs and/or biologics
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development.
Specialist Operations Regulatory Compliance
By Breeze Airways™ At Cottonwood Heights, UT, United States
Bachelor’s degree in an Aviation, government, or judicial related field; Combination of Education and Experience will be considered
Participates in safety meetings and continuing education programs, maintaining close liaison with the FAA, NTSB and industry organizations and associations
Provides oversight to ensure compliance with regulatory requirements and established internal standards
2+ years of experience working for a Part 121 air carrier
Demonstrated abilities in self organization, self-starting work ethic
Strong working knowledge of FAA Advisory Circulars, INFOs SAFOs, 8900.1, SAS and regulatory changes
Regulatory Specialist Jobs
By Addition Management At Manhattan, NY, United States
Knowledge of US regulatory reporting requirements, and financial services-related products.
10+ years of relevant experience, including 5 years of experience preparing regulatory reports.
Prior experience interacting with regulators (preferred)
Track and monitor monthly data source submissions and processing
Liaise with the Technology team to implement and test developed reporting process changes and/or investigate processing issues.
Prepare all necessary FR Y-10 Reports when reportable events occur.
Regulatory Operations Specialist (Remote)
By Partner Therapeutics At Lexington, MA, United States
Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.
Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.
Formal project management training optimal; practical project management skills and recent application required.
Manages communications and activities with third-party publishers and regulatory vendors.
Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.
Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.
Regulatory Specialist - Remote Opportunity
By BevSource At United States
Working knowledge of industry and regulatory requirements
Act as lead project manager for Regulatory projects
5-7 years’ minimum experience in FDA, USDA, and/or TTB Compliance
Knowledge of beverage industry terms and processes
Attention to detail and organizational skills
Strong critical thinking and problem-solving skills
Regulatory Specialist Jobs
By MBO Partners At Charlotte, NC, United States
Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation
Quality Management System/Regulatory Compliance Program
Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations
Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research
Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance
Coordinates review, approval, and dissemination of policies with the internal compliance committee
Ehs Regulatory Specialist Jobs
By Weill Cornell Medicine At , New York, 10065, Ny $40.22 - $50.88 an hour
Demonstrated ability to organize, track, and prioritize work responsibilities and regulatory deadlines.
Bachelor’s Degree or significant work experience in research or academic research administration preferred.
As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices
Provides researchers information regarding the status of registrations; expiration dates, continuing review, committee deadlines and meeting dates.
Must be competent in the use of computers including Microsoft Excel, Word, PowerPoint, Access and email internet programs.
Org Unit: Environmental Health & Safety
Regulatory Labeling Specialist Jobs
By Integrated Resources, Inc ( IRI ) At United States
•Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
•Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE,, etc.).
3) STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT,
4. Experience and/or Familiarity with Structured Content is preferred
•May be responsible for managing projects, processes, or programs with manager oversight.

Are you looking for an exciting opportunity to join a dynamic team and help shape the future of regulatory operations? We are looking for a Regulatory Operations Specialist to join our team and help ensure compliance with regulatory requirements. You will be responsible for developing and maintaining regulatory processes, managing regulatory filings, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for a challenging and rewarding role, then this is the job for you!

Overview: Regulatory Operations Specialists are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with other departments to ensure that all regulatory requirements are met and that the company is in compliance with all relevant laws and regulations. How To Become an Regulatory Operations Specialist: To become a Regulatory Operations Specialist, you will need to have a bachelor’s degree in a related field such as business, law, or public policy. You will also need to have experience in regulatory compliance, and knowledge of the relevant laws and regulations. Regulatory Operations Specialist Skills: Regulatory Operations Specialists must have excellent communication and organizational skills, as well as the ability to interpret and analyze complex regulations. They must also have strong problem-solving skills and the ability to work independently and as part of a team. Regulatory Operations Specialist Knowledge: Regulatory Operations Specialists must have a thorough understanding of the relevant laws and regulations, as well as the ability to interpret and analyze them. They must also have a good understanding of the company’s products and services and how they are affected by the relevant laws and regulations. Regulatory Operations Specialist Responsibilities: Regulatory Operations Specialists are responsible for ensuring that the company’s products and services comply with all applicable laws and regulations. They must also monitor changes in the regulatory environment and ensure that the company is in compliance with all relevant laws and regulations. Regulatory Operations Specialist Experience: Regulatory Operations Specialists must have experience in regulatory compliance, and knowledge of the relevant laws and regulations. They must also have experience in working with other departments to ensure that all regulatory requirements are met. Regulatory Operations Specialist Qualifications: Regulatory Operations Specialists must have a bachelor’s degree in a related field such as business, law, or public policy. They must also have experience in regulatory compliance, and knowledge of the relevant laws and regulations. Regulatory Operations Specialist Education: Regulatory Operations Specialists must have a bachelor’s degree in a related field such as business, law, or public policy. They may also need to complete additional training or certifications in order to stay up to date on the latest regulations. Tools: Regulatory Operations Specialists use a variety of tools to help them stay organized and ensure that the company is in compliance with all applicable laws and regulations. These tools include regulatory databases, compliance software, and document management systems. Good Tips: Regulatory Operations Specialists should stay up to date on the latest regulations and changes in the regulatory environment. They should also be organized and have strong problem-solving skills.

Common Interview Questions:

• What experience do you have in regulatory compliance?
• How do you stay up to date on the latest regulations?
• What challenges have you faced in regulatory compliance?
• How do you ensure that the company is in compliance with all applicable laws and regulations?