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Regulatory Affairs Jobs in Moniteau, Missouri

Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
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.
Regulatory Affairs Specialist Jobs
By DOCS At All, MO, United States
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
Associate Director, Regulatory Affairs, Supply Chain
By Avanos Medical At California, United States
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.
Cmc Regulatory Affairs Consultant
By EPM Scientific At California, United States
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.
Regulatory Affairs Specialist Jobs
By TekWissen ® At Chesterfield, MO, United States
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.
Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)
Regulatory Affairs Fda Consultant
By Arcondis Group At Texas, United States
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.
Manager Regulatory Affairs Pre-Approval Pharma
By CEVA Animal Health, LLC At , Kansas City, Ks
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).
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Remote: Vice President Regulatory Affairs
By Shepherd Regulatory Search At United States
At least 15 years of Global Regulatory Affairs leadership experience.
Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
Provide global regulatory leadership supporting global development.
Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Vice President Regulatory Affairs
By Albion Rye Associates At United States
Offer strategic regulatory counsel to senior management.
Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.
You must have at least 15 years of managerial experience in the medical devices sector.
Head a skilled, diverse regulatory affairs team adept at navigating global regulations.
Devise and execute strategies for prompt global product launch while adhering to regulations.
Assure comprehensive and lawful post-launch product backing.
Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Rn - Registered Nurse - Quality Improvement - Regulatory Affairs - Am
By University of Alabama at Birmingham At , Birmingham

Pay Range: $60,835.00 - $98,855.00 / Year