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Global Regulatory Affairs Coordinator Jobs

Global Regulatory Specialist Jobs
By eBay At Draper, UT, United States
2-5 Years Proven Project Management Experience.2-5 years experience with a federal government agency is preferred.
Effective and confirmed negotiation skills and have the ability to influence decisions and others.
Handle and support critical issues from regulators and monitoring authorities, media, and non-government organizations from around the world.
Support managing and further developing the eBay Regulatory Portal.
Be proficient with eBay’s customer service tools.
Conduct investigations and analysis of non-compliant/potentially criminal conduct.
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion At , $28 an hour
Experience with vendor and supplier management and engagement
Experience with contract management systems for legal agreements and contracts
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.
Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations
A minimum of 3 years' experience in clinical regulatory affairs highly preferred.
Global Customer Experience Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , Westborough, Ma $106,692 - $149,366 a year
Experience and knowledge of all call center KPI & SL metrics.
Experience in driving change via business cases for transformation.
BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.
Experience of managing a critical path regarding customer complaints would be advantageous
Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.
Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
Global Regulatory Affairs Specialist
By ICON At , , Ga
An ambitious regulatory professional with experience of working as Regulatory Specialist across multiple regions. Additional requirements include:
Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
Become part of the supportive and extremely knowledgeable regulatory professional team who are collaborative.
Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
What we can offer you:
Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.
Global Clinical & Regulatory Affairs Coordinator
By Omni Inclusive At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
Manager Global Regulatory Affairs
By The Fountain Group At United States
Expert knowledge of regulations, and experience with interpretation and application
Strong negotiation skills and significant experience in interacting with regulatory authorities
Experience in the development and implementation of CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices
Experience in a pharmaceutical manufacturing facility/development laboratory preferred.
Exp withGlobal responsibility for regulatory submissions and registrations preferred
Risk identification in terms of CMC regulatory strategy
Regulatory Affairs And Compliance Coordinator (Remote)
By MedCerts At United States
Bachelor’s Degree (May be substituted with paralegal certification or experience)
Review and provide interpretation of proposal requirement
Gather information regarding education laws, ordinances, and regulations
Adding new program offerings or modifying program offerings on already approved state and regional ETPL approvals
Experience as a Certified Nursing Assistant
Fully remote working environment with equipment provided by MedCerts
Global Regulatory Lead (Contract)
By Life Science People At United States
Excellent project management skills, with the ability to effectively prioritize and manage multiple projects simultaneously.
Possess knowledge of Orphan Drug Documentation and familiarity with the regulatory requirements specific to orphan drug development.
Manage regulatory project timelines, ensuring adherence to deadlines and milestones.
Have a thorough understanding of the CTA process, with global experience in this area considered a bonus.
Bachelors degree and minimum 8+ years of progressive experience in Biotech/Pharma Regulatory Affairs.
5+ years of experience Regulatory Strategy
Global Regulatory Affairs Specialist
By ChromaDex At United States
Conduct cost/benefit/risk analyses and recommend options or proactive solutions to assure regulatory compliance of ChromaDex
Excellent oral and written communication skills
Excellent organizational skills and ability to multitask
Whip smart - we’re looking for candidates with a keen intellect who quickly learn what they don’t know
Adaptable – Able to apply yourself on a wide variety of tasks on a daily basis
Analytical - Can assess and leverage systems and processes to figure out more effective ways to get things done
Regulatory Affairs Coordinator Jobs
By Volt At Red Wing, MN, United States
Investigate, maintain, and manage regulatory product certification claims data, databases, documentation systems.
Ensure accurate data entries, database management.
Maintain clear, concise documentation, experienced in documentation control/coordination.
Review technical documents to retrieve information with high level accuracy.
Can read/understand technical documents such as product drawings, test reports, user instructions, product labels, specifications, standards, product claims etc.
As a Regulatory Coordinator you will
Business Affairs Coordinator, Global Brand Studio And Events
By TikTok At New York, United States

Responsibilities TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los Angeles, New York, ...

Intern, Global Regulatory Operations
By Viatris At , Remote $20 an hour
Provide support for data research/verification, system training support, data entry, and system testing
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Sr Manager, Global Regulatory Affairs
By GSK At , Durham, 27701, Nc
More than 8 years of experience in regulatory affairs.
8+ years of experience in managing teams and leading in a matrix organization.
8+ years' experience with US regulatory environment.
Experience at a large global pharmaceutical or vaccines company
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
We are looking for professionals with these required skills to achieve our goals:
Director, Global Regulatory Affairs
By NextPoint Therapeutics, Inc. At Cambridge, MA, United States
Experience managing annual reports, IND amendments, IB updates, DSURs for lifecycle management of our pipeline programs.
Lead and manage all interactions/meetings with FDA and other health authorities.
Lead and manage preparation and submission of all regulatory documents across clinical and pre-clinical programs, including authoring where necessary.
Experience with oncology drug development required, experience in immuno-oncology drug development strongly preferred.
Experience with filing INDs required. Experience with direct interactions with FDA required.
Experience with biomarker strategies preferred, experience with companion diagnostic development a plus.
Assoc. Director / Director, Global Regulatory Affairs
By AVROBIO At , Remote
Experience interacting with the FDA and ex-US health authorities and current knowledge of global regulations, and guidance’s/guidelines
Experience in the development and preparation of successful regulatory strategies
Cell and gene therapy and/or rare disease experience preferred
Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
Develop and implement global regulatory strategies including timings for regulatory interactions, pediatric development, orphan drug designations and routes to approval
Highlight and mitigate potential risks to timelines and deliverables
Operations Manager, Global Business Affairs
By Condé Nast At New York, NY, United States
Experience in financial and project management softwares and knowledge of Airtable a plus.
Work cross-functionally with teams including Creative, Production, Finance, Sales, Marketing, Legal, Editorial, and more.
3-5 years in Operations or relevant industry experience.
Experience within a global or multi-faceted organization highly desirable.
Demonstrated experience in rolling out new processes to large teams.
Knowledge of basic financial terminology within the media or publishing industry highly desirable.
Regulatory Affairs Coordinator Jobs
By Orion At , Danvers, Ma $42 an hour
Must be results oriented with excellent organizational and time management skills.
1-3 years of Regulatory Affairs experience required.
IVD Regulatory Affairs or Quality Assurance experience is very beneficial and highly desirable.
Excellent MS Word and MS Excel skills, Strong, independent worker capable of operating in a fast-paced, constantly changing environment.
A self-starter able to manage their own workload and prioritize tasks accordingly.
Excellent attention to detail. Must possess strong interpersonal and communication skills.
Global Regulatory Lead & Head Of Regulatory Labeling
By Karyopharm Therapeutics Inc. At , Remote $175,000 - $300,000 a year
Knowledge of global regulatory requirements
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements
Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space
Preferences include recent successful NDA experience, as well as experience within a matrix environment
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Associate Director, Global Regulatory Sciences, Oncology
By Bristol Myers Squibb At San Diego, CA, United States
Ph.D., M.D., PharmD. , MS or commensurate experience
Significant experience in regulatory affairs (e.g. 3-5 years)
Direct experience in developing strategy and leading teams through interactions with FDA.
Extensive experience in initiating and conducting successful interactions within FDA.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
Provide strategic direction (and content input) on US Labeling
Specialist, Global Regulatory Affairs - Development Strategy
By Alexion Pharmaceuticals,Inc. At , New Haven, Ct
Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
0-2+ year(s) experience in Regulatory Affairs within the pharmaceutical industry
Good English oral and written communication skills
Ability to understand and interpret regulatory requirements and translate this into concrete propositions
Initial experience on regulatory submissions
Prior experience in pharmaceutical industry