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Regulatory Operations Specialist Jobs in California

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 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 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 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?