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Regulatory Affairs Associate Jobs in Iowa

Associate Iii, Regulatory Affairs
By Sandoz At , Princeton $97,600 - $146,400 a year
Effectively monitor and track information and requirement changes
Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals
Excellent oral and written communication skills
Pharmaceutical or generic drug experience in a regulatory capacity
Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)
Senior Regulatory Affairs Associate, Fsp
By Parexel At , Remote
Management Strong management with depth of experience working for global health authorities.
Experience with project lifecycle and management
Strong management with depth of experience working for global health authorities.
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.
Interacts professionally at multiple levels including senior management within a client organization.
Successfully penetrates executive management levels or other business units within a client organization.
Clinical Affairs Associate Jobs
By Exact Sciences Corporation At , Remote $49,000 - $78,000 a year
Review for completeness and route legal documents for execution. File all versions in document management database.
Maintain applicable clinical study data in Clinical Trial Management System.
Support and comply with the company’s Quality Management System policies and procedures.
General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
Provide support to Clinical Study Manager for clinical study budget review, tracking, and maintenance.
Strong verbal and written communication skills.
Regulatory Affairs Associate Jobs
By BeiGene At , Remote $33.99 - $46.01 an hour
Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (nonclinical, clinical)
Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations
Project Management - Communicates changes and progress; Completes projects on time and budget.
With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical
Senior Clinical Affairs Associate
By Exact Sciences Corporation At , Remote
Review for completeness and route legal documents for execution. File all versions in document management database.
Maintain applicable clinical study data in Clinical Trial Management System.
Support and comply with the company’s Quality Management System policies and procedures.
Thorough knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines.
Provide support to Clinical Study Manager for clinical study budget review, tracking, and maintenance.
Strong verbal and written communication skills.

Are you looking for an exciting opportunity to join a growing Regulatory Affairs team? We are looking for a Regulatory Affairs Associate to join our team and help us ensure compliance with regulatory requirements. You will be responsible for preparing and submitting regulatory documents, monitoring regulatory changes, and providing guidance on regulatory requirements. If you have a passion for regulatory affairs and are looking for a challenging and rewarding role, this could be the perfect job for you!

A Regulatory Affairs Associate is responsible for ensuring that a company’s products comply with all applicable laws and regulations. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing regulatory support to other departments.

What is Regulatory Affairs Associate Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects and prioritize tasks
• Attention to detail
• Proficiency in Microsoft Office

What is Regulatory Affairs Associate Qualifications?

• Bachelor’s degree in a related field such as biology, chemistry, or engineering
• Regulatory Affairs Certification (RAC) is preferred

What is Regulatory Affairs Associate Knowledge?

• Knowledge of FDA regulations and guidelines
• Knowledge of international regulatory requirements
• Knowledge of Good Manufacturing Practices (GMPs)

What is Regulatory Affairs Associate Experience?

• Previous experience in a regulatory affairs role is preferred
• Experience in the pharmaceutical or medical device industry is a plus

What is Regulatory Affairs Associate Responsibilities?

• Research and interpret applicable laws and regulations
• Prepare and submit regulatory documents
• Monitor changes in regulatory requirements
• Provide regulatory support to other departments
• Maintain regulatory records
• Liaise with regulatory agencies
• Ensure