Regulatory Affairs Intern Jobs in Missouri

Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.

Maintain and updates information about global regulatory requirements.

4+ years of Regulatory Affairs experience

Post-graduate and/or certification/ license may be required.

Review product labeling and marketing materials for accuracy and compliance with regulations.

Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.

Manage and submit monthly, biennial and annual renewals for assigned products.

BA/BS in a field of science, business, or a related degree plus 2 years of regulatory experience

Experience interpreting and complying with laws & regulations to support regulatory submissions/approvals.

Highly developed written and oral communication skills.

Experience successfully managing information in databases.

Ability to multitask and manage multiple projects in a fast-paced environment.

Proficiency in project management and ability to handle multiple projects simultaneously.

In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.

Excellent written and verbal communication skills.

Serve as the main liaison between clients and FDA, facilitating effective communication and swift resolution of issues.

Keep abreast of changes in FDA regulatory guidelines, standards, and policies, interpreting their implications for client projects.

Advise clients on the clinical data necessary to support device and drug approval, including the design and review of clinical studies.

Understanding IND process with a thorough knowledge of ICH and associated regulatory guidelines.

With a minimum of 2-4 years of regulatory affairs experience (TFDA/ IRB)

Excellent organizational skills and ability to prioritize and multi-task.

Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.

Liaise with officials of Government agencies to facilitate evaluation processes and respond to requests for data in agreed timeline.

Perform TMF QC for regulatory activities, complete archiving requests/checks for regulatory submissions, and conduct the study/task-based trainings per needs

Provide leadership to maintain compliance with domestic and international regulations as well as management of the Avanos Mexico facilities’ State Licenses.

Continue to increase education/knowledge in the area of Regulatory Affairs.

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;

Eight to ten years experience in Regulatory Affairs.

Exceptional written and verbal communication skills.

Team player with excellent organizational skills.

Participate in the design, development and execution of regulatory strategies, regulatory risk management and contingency plans.

Proactively manage CMC aspects including overseeing preparation and submission of CMC submissions - including clinical trial applications.

Develop and assess CMC content to ensure it is complete, well-written, and meets all pertinent requirements.

10+ years’ experience in life sciences

5+ years’ relevant experience in regulatory affairs or related functions in drug or biologics development.

Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.

Prepare regulatory assessments for project teams, line management, and key stakeholders as requested. Includes support for due diligence evaluations.

High level knowledge of registration dossier preparation for US FDA/CVM. Including development, drawing conclusions and effect of changes.

Proactively monitor, evaluate, communicate existing and new US regulations impacting products and projects. Assess the potential impact and/or opportunities.

Interface with regulatory authorities on new product development and registration programs, as well as industry associations.

Coordinate technical input for preparation / review of FOI summary and label language for assigned projects.

Maintain database(s) for tracking regulatory correspondence, communications, submissions, critical dates, and commitments. Ability to effectively use FDA/CVM submission system (E-submitter).