Prepare, compile & review Regulatory/Quality documents to support submissions to various markets
Prepare deficiency responses, review labeling information, product monographs and marketing materials under supervision
Prepare post approval supplements / annual reports to support changes and/or manage the regulatory product life cycle as applicable
Seek guidance from other team members and manager as needed, and enhance Regulatory knowledge
Perform additional duties as assigned by the manager
Create and/or revise raw material and packaging specifications using client global specification systems.
Create and manage global change controls for these revisions to the raw material and packaging specifications.
Coordinate and interact with various internal departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites, Suppliers and Distributors to understand the change, impact assessment, implementation strategy and required documentation governing the change
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
Introduction As an Application Developer, you will lead IBM into the future by translating system requirements into the design and...
Apply For This JobAtologist Infotech is a vocational web application development company in India offering excellent solutions to the clients since its commencement....
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Description : Work Location: Sector 126, Noida Work Timings: Rotational Shifts, Person should be comfortable...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> We are looking for a detail-oriented accountant to perform and coordinate accounting duties within our...
Apply For This JobFull Job Description Overview: The Facilities and Admin Manager is responsible for facilitating efficient operations and management of day-to-day facilities...
Apply For This JobJob Description Whole9yards is a Multi-Channel E-Commerce Retailer of multiple product categories in the USA and Indian E-Commerce space. We...
Apply For This Job