- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk ... and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document (CTD). May oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may ... QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the… more
- Merck & Co. (Rahway, NJ)
- …regulatory agencies and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and ... or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV Quality (DSI/DSE) reports to the Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors ... that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within… more
- Merck & Co. (Rahway, NJ)
- …for our Biologics pipeline. As part of this role, they will author and review CMC sections of regulatory submissions and associated source technical reports and ... Job DescriptionPosition Description: Associate Principal Scientist - Biologics Potency We are...to assess the potency of drug candidates. Experience with multiple techniques and technologies, eg flow cytometry or lab… more
- Merck & Co. (Rahway, NJ)
- …Develop guidance and tools to scale tumor team franchise strategies across multiple products Execute GRL interviews to begin change management process and support ... in Oncology or Hospital/SpecialtyExperience in company end-to-end medical/legal (Promotional Review Team) review and delivery processes.Experience with… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate , Regulatory Review works closely with ... create various components of each submission for a Manager, Regulatory Review or Senior Associate ,...+ Produce and assemble submission packages + Comfortably handle multiple projects and work with multiple teams… more
- Publicis Groupe (New York, NY)
- …Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review must follow ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (New York, NY)
- …www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Sr Manager, Regulatory Review is responsible for managing a ... the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a...to meet all deadlines. **DUTIES & RESPONSIBILITIES:** + Manage multiple direct reports at the Associate , Senior… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** ** Associate Director, Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory Affairs ... and regulatory submissions including assisting in preparing submissions, protocol review , and conducting research on regulatory guidance's or competitive… more
- Bausch Health (Bridgewater, NJ)
- …compliance with regulatory agency requirements. Responsibilities **:** + Provides regulatory review of advertising and promotional materials, new campaigns ... review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with the ability… more
- SMBC (New York, NY)
- …futures, treasury futures & options, etc. CM is looking to hire a Policy Governance Associate or Vice President in their Regulatory and Control Group. The group ... is responsible for managing regulatory and internal audit matters, business processes, and policy...Manage and enhance CM's policy governance framework to develop/write, review , approve, publish, communicate, retire and maintain policy related… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … activities, and representing Regulatory to cross-functional teams for multiple products. + Experience chairing/leading promotional review committees or ... relevant experience. + For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products. +… more
- Publicis Groupe (New York, NY)
- …or just an all-around nice person, let's chat. **Job Description** The Manager, Regulatory Review is responsible for ensuring regulatory submissions follow ... delivery. This role may have direct reports at the Associate /Senior Associate level as appropriate. Core Duties...Account teams as they prepare projects for Medical Legal Regulatory (MLR) review + Submit completed materials… more
- SMBC (New York, NY)
- …offers a competitive portfolio of benefits to its employees. **Role Description** The Regulatory Officer works with the Governance Regulatory Team within SMBC's ... Planning Department to assist with the execution of regulatory relations and exam management for SMBC. This role...collection of documents before, during, and after on-site examinations review and performs due diligence review to… more
- Morgan Stanley (New York, NY)
- …(M/F/Disability/Vet). **Job:** **Investment Banking/Sales/Trading/Research* **Title:** *IED - Regulatory Control Group - Analyst/ Associate * **Location:** ... The position available is an Analyst or Associate level position within the Institutional Equity Risk...the Institutional Equity Risk Management team, specifically within the Regulatory Control Group (RCG). RCG is responsible for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing… more
- Actalent (Fairfield, NJ)
- …be responding to customers via email and cell phone follow-up They will review all compliance documentation for personal care products Skills: Safety Data Sheets, ... Regulatory , qms, crm, lims Additional Skills & Qualifications: Must...have a technical Bachelor's Degree 1-2 years experience in multiple industries Experience with safety data sheets Experience with… more
- Merck (Rahway, NJ)
- … agencies and/or subsidiaries for all applications and submissions. + Responsible for regulatory review and final approval of all submissions and associated ... strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously. + Provide leadership to the… more
