Register
Recruit Create CV

Regulatory Operations Specialist Jobs

Regulatory Operations Specialist Jobs
By CymaBay Therapeutics At Newark, CA, United States
Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates
Manage the regulatory activities log tracking annual and current submissions
Direct publishing experience a plus
Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.
Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs
Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills
Regulatory Operations Specialist Jobs
By LeadStack Inc. At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Arranges event planning for internal meetings and Kaizen events, including ordering supplies, coordinating meals, arranging hotel room blocks, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
Title: Global Clinical & Regulatory Affairs Operations Coordinator
8:00 AM - 5:00 PM EST (includes one hour lunch)
Remote Regulatory Specialist ($28.00 - $31.25 / Hour)
By Talentify.io At United States
Bachelor's Degree and 3-5 years of relevant experience or equivalent combination of education and experience.
Knowledge and experience with FDA Clinical Trial regulations and guidance.
3 years of relevant experience in an academic regulatory environment.
Experience with IND/IDE/Clinical Trial Application.
Process initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Board (IRB).
Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees.
Regulatory Operations Associate Jobs
By Elsevier At Philadelphia, PA, United States
Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions.
Providing Electronic Document Management System (EDMS) user support for team members.
Electronic Document Management System (EDMS)
Representing Reed Tech and address the client’s business requirements and needs.
Experience with DocuBridge and Veeva Vault RIM preferred.
Excellent Word and Adobe Acrobat skills required.
Senior Manager, Regulatory Operations
By Ionis Pharmaceuticals, Inc. At United States
Experience leading the management of projects/timelines and collaborating with team members
Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems
Expertise in the use of document management and eCTD publishing systems
Previous experience developing work instructions and generating SOP’s that are consistent with global regulatory requirements and company business practices
Proven ability to manage, streamline and collaborate to improve document preparation and management systems
Minimum of 5 years prior experience in a Regulatory Operations group within the industry, Pharmaceutical or Biotech Company preferred.
Manager, Regulatory Operations - Remote
By Oscar Health At United States
Project management and process improvement experience
Proficiency in designing and improving workflows, and demonstrative project management experience.
5+ years of healthcare industry regulatory analysis experience, in the health plan/managed care space.
Project manage the internal tracking and monitoring of Regulatory Operations team deliverables related to our Legislative processes.
A bachelor's degree in a legal, healthcare-related or humanities field, or 4 years commensurate experience.
Be the EOC SME for the regulatory operations ecosystem and current strengths, weaknesses, and gaps within important region(s)
Regulatory Specialist Jobs
By Top Quality Recruitment (TQR) At Dallas, TX, United States
Complete all other duties as assigned by management.
Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.
Research of International, Federal, State, local, and internal regulatory requirements
Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.
Assisting with obtaining, and/or renewing relevant national certifications.
Work closely with the Quality Manager and Product Development teams to ensure compliance.
Regulatory Specialist Jobs
By Eliassen Group At United States

Years of regulatory specialist experience in a clinical trial environment (ie premarket)

One or more of the Regulatory Certifications- AAAHRP, SOCRA, PRIM&R and similar organizations. GCP training and/or certification

Regulatory Specialist Jobs
By BCforward At New York, NY, United States
5+ years minimum relevant experience
Prior experience in regulatory driven remediation e.g., MRA, Consent Order etc. and advantage.
Experienced in working with stakeholders
BCforward is currently seeking highly motivated Regulatory Control Lead @New York/Jersey City, NJ or Tampa.
We place consultants for end clients all over USA.
Location: New York/Jersey City, NJ or Tampa
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 Specialist Jobs
By Mindlance At California, United States
EDUCATION AND EXPERIENCE YOU’LL BRING
Previous experience working in a highly matrixed and geographically diverse business environment
Proficient with MS Office suite (Word, Excel, Outlook)
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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
Regulatory/Qa Specialist Jobs
By Key Corporate Services, LLC At Florida, United States
Our client offers a competitive salary along with full benefits and 401K match
2+ years of experience in the Pharma/Biotech space
2+ years of experience in a Quality or Regulatory position
Role reports directly to the VP of Lab Operations who fosters an environment of learning and growth for their team
Join a stable company that has been in business for over 30 years
BS or higher in a relevant scientific field
Regulatory Specialist Jobs
By Top Quality Recruitment (TQR) At Cape Coral, FL, United States
Complete all other duties as assigned by management.
Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.
Research of International, Federal, State, local, and internal regulatory requirements
Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.
Assisting with obtaining, and/or renewing relevant national certifications.
Work closely with the Quality Manager and Product Development teams to ensure compliance.
Regulatory Operations Analyst Jobs
By AmerisourceBergen At Pennsylvania, United States
Working knowledge of purchasing, inventory management, order processing, invoicing, customer returns, receiving, Manufacturer returns and inventory control systems
Excellent data entry and computer application skills
Ensure data accuracy and integrity of managed information is maintained for all supported processes in order to avoid rework.
Normally requires one (1) to two (2) years directly related and progressively responsible experience.
Knowledge of ABC policies, programs & services and products
Problem-solving skills; ability to resolve issues effectively and efficiently with general supervision
Regulatory Specialist Jobs
By Indenovo Global Search & Selection At New York City Metropolitan Area, United States
Detail-oriented with exceptional organizational and time management skills.
5 years of regulatory affairs experience in the [industry] sector.
Knowledge of current US & Global regulations pertaining to flavor & fragrance industries
Knowledge of WERCS, Oracle, AS/400
Proven ability to interpret and implement regulatory requirements.
Excellent communication, analytical, and problem-solving skills.
Vp, Regulatory Operations Jobs
By Exelixis, Inc. At , King Of Prussia, Pa $316,750 - $368,250 a year
Accountable for ensuring regulatory information management platforms comply with global and regional submission requirements.
Accountable for regulatory operations sourcing strategy, vendor management, and management of vendor costs
Equivalent combination of education and experience.
Deep knowledge and understanding of the drug development process and regulatory requirements and environment
Strong interpersonal skills and the ability to manage, develop, and mentor personnel in a matrix environment skillfully and appropriately
Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,
Intern, Global Regulatory Operations
By Viatris At , Remote $20 an hour
Provide support for data research/verification, system training support, data entry, and system testing
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Specialist Jobs
By ARServices At Fort Belvoir, VA, United States
Detail-oriented, self-starter with excellent communication and time management skills.
Liaison for DTRA STMs and PMs, project team and line management, with USAMRDC Office of Human and Animal Research Oversight (OHARO)
Experience meeting regulatory requirements for early research involving human and animal subjects
Knowledge of the DoD acquisition policies, preferably with experience in the Joint CBDP
Minimum of two years’ experience with a BS, or 1 year with a MS.
Experience with the DoD Joint Chemical Biological Defense Program (CBDP)
Junior Regulatory Specialist Jobs
By Worley At , Houston, Tx
Track record of successful management of projects / work packages to meet agreed budget and schedule
Requires knowledge of reciprocal effects of work upon other fields.
3+ years of professional experience, preferably with an environmental consulting organization, an operator, contractor or regulator
Excellent client and agency interfacing skills
Competitive and comprehensive compensation, benefits package
Opportunities to integrate into engineering and project delivery to deliver meaningful benefits to the environment and communities

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?