- embecta (Parsippany, NJ)
- …diverse and global employees. This position will be responsible for providing regulatory strategies and execution on embecta growth initiative projects. The role ... life cycle management activities which include identification and interpretation of regulatory requirements, review and preparation of regulatory submissions… more
- Actalent (Branchburg, NJ)
- Job Title: Regulatory Label SpecialistJob Description The Safety Data Sheet & Product Labeling Specialist is responsible for ensuring compliance with global ... and associated hazard communication materials to support product stewardship and regulatory compliance. Responsibilities + Develop, review, and maintain Safety Data… more
- System One (Summit, NJ)
- Job Title: QA CTO Label Specialist Location: Summit, NJ Type: Contract Hours: 2 nd Shift , Wed-Sat- 4:00pm-2:00am. Compensation: $27 - $34.95 hourly Contractor ... Work Model: Onsite Full Job Description: The Label Control Specialist is responsible for supporting...by Management. * Maintains knowledge of current GMPs and regulatory guidelines. REQUIRED COMPETENCIES: + BS Degree required, minimum… more
- Kelly Services (Bridgewater, NJ)
- …resolve any conflicts of reviewer feedback on labeling content + Work closely with Label Requirement Specialist (LRS) Coordinator to align & interpret LRS into ... **Global Labeling Lead Specialist ** Kelly(R) Science & Clinical is seeking a...US only artwork, MDD, MDR, new product launches, private label or regional/country specific lens/lens care. Responsibilities: + Work… more
- Pfizer (New York, NY)
- …the design, execution and interpretation of studies in support of worldwide regulatory submissions. The individual will be accountable for creating and gaining ... May provide specialized monitoring support if required + Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and… more
- Sanofi Group (Bridgewater, NJ)
- …structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications ... for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the...Required Qualifications:** + Medical Doctor (MD) preferred: GP or specialist , English fluent (spoken and written) + At least… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for patients through the duration of the course of therapy. While the sales specialist drives new business demand, the ARM leads the "pull-through" process on open ... uncompromised ethics and integrity while helping others understand legal and regulatory parameters related to anti-kickback statutes, fraud and abuse, off- label… more
