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Regulatory Affairs Analyst Jobs in Iowa

Regulatory Affairs Professional Jobs
By Sartorius At , Remote
Deep knowledge of the relevant Regulatory requirements
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
8+ years relevant experience within the Regulatory Affairs discipline
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
Proven analytical skill and technical/scientific competence.
Strong initiation and organizational 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
Regulatory Affairs Sr Specialist (Remote)
By Zimmer Biomet At , Remote $98,700 - $122,500 a year

Requisition Number AMER27218 Employment Type Full-time Location Virtual Office - Indiana Job Summary Zimmer Biomet is a global medical technology leader. Our team members are ...

Are you looking for a challenging and rewarding career in Regulatory Affairs? We are looking for a Regulatory Affairs Analyst to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory requirements, preparing regulatory submissions, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for an opportunity to make a difference, this could be the perfect job for you!

A Regulatory Affairs Analyst is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for researching, interpreting, and communicating regulatory requirements to internal stakeholders, as well as providing guidance on regulatory compliance.

What is Regulatory Affairs Analyst Job Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office Suite

What is Regulatory Affairs Analyst Job Qualifications?

• Bachelor’s degree in a related field such as law, public policy, or business
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (e.g. Regulatory Affairs Professional Society (RAPS) certification)

What is Regulatory Affairs Analyst Job Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment and its impact on business operations
• Knowledge of the product development process
• Knowledge of the regulatory submission process

What is Regulatory Affairs Analyst Job Experience?

• Previous experience in regulatory affairs
• Experience in a related field such as law, public policy, or business

What is Regulatory Affairs Analyst Job Responsibilities?

• Research and interpret applicable laws and regulations
• Develop and maintain regulatory compliance strategies
• Prepare and submit regulatory documents
• Monitor regulatory changes and updates
• Provide guidance and advice on regulatory compliance
• Liaise with internal and external stakeholders
• Track and report on regulatory compliance activities