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Regulatory Information Specialist Jobs in California

Product & Regulatory Specialist Jobs
By 80Twenty At Alhambra, CA, United States
Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.
Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.
Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.
Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.
Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.
Strong attention to detail and organizational skills.
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 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

Are you looking for an exciting opportunity to use your regulatory knowledge to make a difference? We are looking for a Regulatory Information Specialist to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory information, preparing reports, and providing guidance to our team. If you are a detail-oriented professional with a passion for regulatory compliance, this could be the perfect job for you!

Overview Regulatory Information Specialists are responsible for ensuring that organizations comply with all applicable regulations and laws. They are responsible for researching, analyzing, and interpreting regulations and laws, as well as providing guidance and advice to organizations on how to comply with them. Detailed Job Description Regulatory Information Specialists are responsible for researching, analyzing, and interpreting regulations and laws, as well as providing guidance and advice to organizations on how to comply with them. They must be knowledgeable about the various regulations and laws that apply to their organization and be able to identify potential areas of non-compliance. They must be able to communicate effectively with all levels of the organization and be able to explain complex regulations and laws in a clear and concise manner. They must also be able to develop and implement strategies to ensure compliance with all applicable regulations and laws. Job Skills Required
• Knowledge of applicable regulations and laws
• Ability to research, analyze, and interpret regulations and laws
• Ability to communicate effectively with all levels of the organization
• Ability to explain complex regulations and laws in a clear and concise manner
• Ability to develop and implement strategies to ensure compliance
• Ability to identify potential areas of non-compliance
• Ability to work independently and as part of a team
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in a regulatory or compliance role
• Knowledge of applicable regulations and laws
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to research, analyze, and interpret regulations and laws
• Ability to develop and implement strategies to ensure compliance
Job Knowledge Regulatory Information Specialists must have a thorough knowledge of applicable regulations and laws, as well as the ability to research, analyze, and interpret them. They must also have a good understanding of the organization’s operations and be able to identify potential areas of non-compliance. Job Experience Regulatory Information Specialists must have at least two years of experience in a regulatory or compliance role. They must also have a thorough knowledge of applicable regulations and laws, as well as the ability to research, analyze, and interpret them. Job Responsibilities
• Research, analyze, and interpret applicable regulations and laws
• Provide guidance and advice to organizations on how to comply with regulations and laws
• Develop and implement strategies to ensure compliance with