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.
UI/UX_ Application Developer_ Bangalore_ Institutional Securities Tech Company Profile Morgan Stanley is a leading global financial services firm providing a...
Apply For This JobJob Description Skills**: 4+ years’ experience in B2B digital marketing and advertising Excellent grasp of social media and website metrics...
Apply For This JobSummary To serve Food & Beverage to guests in the assigned Place of Work, provide a courteous, professional, efficient and...
Apply For This JobAbout the job The Red Hat DXP Quality Engineering (QE) team is looking for a Senior Software Quality Engineer to...
Apply For This JobNetwork18 is India’s largest platform-agnostic news media powerhouse, offering a comprehensive footprint across various Indian languages on Television, Digital &...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Desired Candidate Profile – For more details or instant reply, Just-send ‘Hi’ through-WhatsApp on this...
Apply For This Job