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Regulatory Operations Specialist Jobs in Pennsylvania

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.
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
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,

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?