Regulatory Labeling Manager (Us-Remote)
By Amgen At , Los Angeles $95,277 - $134,309 a year
Project Management experience, experience managing individual and group projects of moderate complexity
Experience working in a Documentum-based document management system
Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone
Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
Manages the review and approval of core DHCP letters
Regulatory Affairs Program Manager, Us
By ZEISS Group At Dublin, CA, United States

The Regulatory Affairs Program Manager US is responsible for developing and monitoring regulatory submission timelines for a variety of US medical device submissions (such as 510(k)s, IDEs and/or ...

Associate, Regulatory - Legal Us
By PIMCO At Austin, TX, United States
Able to generate solutions and appropriately escalate to management
Minimum 3 years of law firm / in-house paralegal or regulatory compliance experience
Financial product and/or securities law knowledge is a plus
Strong analytical skills and meticulous attention to detail
Able to take initiative in learning and applying new skills
Coordinate responses to various information requests, including 3rd party, client, and investor requests related to various legal / regulatory topics
Regulatory Affairs Specialist Us & Canada
By Valagro At United States
· Effective time management & project planning skills.
· Must have knowledge of U.S and European product submission and registration requirements.
· Ability to work independently, taking ownership of the management of processes, projects, and timelines.
· This is a remote position; the ideal candidate will work from home.
Permanent review of the labels in order to make them compliant with new regulatory requirements and chemical/physical parameters;
· 5 to 8 years hands-on submission experience including the developing and execution of regulatory strategies.
Director, Us Medical Affairs Neuropsychiatry
By Biogen At Weston, MA, United States
Relevant experience in Psychiatry required (specifically mood disorders)
Experience in evidence generation required
Experience and expertise with digital medical solutions, processes, and systems
Strong working knowledge of US regulations as relevant to Medical Affairs
Experience with medical launch as well as products at different stages of the lifecycle
Ability to manage projects and take initiative to solve complex and challenging problems
Regulatory Intern Jobs
By Tarte Cosmetics At New York, NY, United States
Manage Regulatory Information for New Product Development (NPD)
Support retail teams for registration in international markets
Execute and assist in registration process by submitting formulations for third-party review
Review documentation for accuracy and compliance with US and international markets
Highly motivated with the ability to thrive and multi-task in a fast-paced and demanding environment, passionate about cosmetics.
Request and submit samples for testing
Summer Associate - Regulatory
By Rare Beauty At El Segundo, CA, United States
Strong time management skills with ability to effectively prioritize tasks
Updating internal project trackers and project management systems
Strong written and verbal communication skills
Assist with day-to-day regulatory operations (formula review, filings, formula testing, sample shipping, document organization, etc.)
Help collect formulas and documents from manufacturers to support the product safety and regulatory review process
Assist with international product registrations and global compliance reviews
Clinical Affairs Associate I (Remote: Us)
By Ambry Genetics At Carson City, NV, United States
Excellent time management and organizational skills.
Be a liaison between genetic counseling services and other internal departments, including updates to management regarding genetic counseling services
Flexibility with regard to job assignments. Excellent skills in Microsoft Excel and PowerPoint Knowledge of Progeny database.
TECHNICAL COMPETENCIES (Skill, Abilities and Capabilities):
Assist Manager, Clinical Affairs and other team members in fulfillment of client requests for data as needed.
Excellent telephone and communication skills.
Summer Internship, Editorial Intern | The Ringer (Us)
By Spotify At , Los Angeles, Ca $27 an hour
You have demonstrated experience with a digital publication that you can tell us about
For this role, you can also choose to either work from home or from one of our office locations
Los Angeles or Remote Americas
Fact check editorial for The Ringer, using research best practices, topical awareness, and sound journalistic judgment
Use the CMS Chorus to build pages for publication on the website
Complete general research assignments as needed by our editors and writers
Regulatory Affairs Intern Jobs
By Flywheel.io At United States
Assist with researching regulatory compliance requirements, reviewing company policies, standards, procedures, and training material.
Other responsibilities as required and assigned by the Executive Director of Regulatory Affairs
A reliable self starter with exceptional computer and software skills
Experience with employee training programs for multiple compliance standards
Any compliance and regulatory functional experience in biomedical informatics supporting clinical trials both nationally and internationally
Assist in overseeing an employee regulatory compliance training program following a responsibility matrix while maintaining accurate training records.
Summer Internship, Editorial Intern | The Ringer (Us)
By Spotify At United States
You have demonstrated experience with a digital publication that you can tell us about
For this role, you can also choose to either work from home or from one of our office locations
Fact check editorial for The Ringer, using research best practices, topical awareness, and sound journalistic judgment
Use the CMS Chorus to build pages for publication on the website
Complete general research assignments as needed by our editors and writers
Execute other general tasks as needed in the editorial department
Summer Intern, Regulatory Affairs
By Planet Pharma At United States
Intern Qualifications and SkillsPursuing a bachelor’s, or graduate degree in life sciences
Ability to manage workload effectively including planning, organizing, prioritizing, and meeting deadlines
Ability to apply scientific and/or business knowledge to assigned projects
Effective writing skills, with high attention to detail
Review of Global Regulatory submission documents to obtain correspondence information and feedback between the company and the health authority agency
Prepare a final presentation on research, and overall learning through the internship project for the intern symposium
Intern, Regulatory Affairs - Spine
By MCRA At , Washington, 20001, Dc $20 an hour
Analytical with strong literature-based research skills
Strong written and verbal communication skills
Experience reading technical reports and extracting data.
Location: DC-based internship with hybrid in-office and remote schedule
Bone Void Fillers historical control development
Catalog of Spine submissions / Marketing Deck or client handout / Submission Timing Reference Sheet + Submission Tracker
Us Regulatory Affairs Summer Intern
By Johnson & Johnson At , Somerville, 08876, Nj $29 an hour
Support the acquisition and management of technical products and process files to meet applicable regulations
Data analytics from regulatory information management systems (RIM) and reports / dashboards / presentations development.
Assist in the compilation of requirements for global regulatory submissions of our products
Attend project team meetings with RA lead to assist in strategic discussions to hone team collaboration skillset
Assignment location may be onsite or remote, per business needs.
Summer Internship Program Experiences Include: