- 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
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist Labeling** Kelly(R) Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based in ... all labels are compliant with regulations, guidance, internal quality process, and label control/issuance. Responsible for final product label review and… 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