Cmc Regulatory Affairs 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.

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

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.