- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- … regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMACompetencies:Advanced knowledge of ... rare diseases and immune disorders.Job Summary: This position manages multiple biological developmental projects with supervision, including working with contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... and ensuring adherence to timelines.Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Fidelity TalentSource LLC (New York, NY)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Job Description:RoleAs a Senior Associate , you will help to provide H&W clients...skillsYou have a strong aptitude to balance and prioritize multiple projects in a fast-paced work environmentYou have an… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... experience at financial services institutions, eg, asset managers, banks, regulatory agencies (required)Experience with brokerage products and services, brokerage… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... improve our productivity; guides junior team members on technologyCollaborate with multiple stakeholders/large cross functional teams as part of work deliveryFollows… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... queries and analytical tools and methodologies including SQLEffectively manages multiple initiatives and responsibilities within prescribed timelinesAbility to engage… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …database to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is responsible for content development, ... compilation, maintenance, and review of the Quality Module for regulatory ...meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface… more
- Haleon (Warren, NJ)
- …projects. **What will your individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as follows: + Work within ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do career defining...in the market by using strategies and coordinating with multiple departments to achieve a product fit for the… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director, North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director, ... can reach their potential. At Johnson & Johnson, we all belong. The Associate Director, Regulatory Affairs will be responsible for the development,… 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
- Mizuho Corporate Bank (New York, NY)
- …control enhancements. Summary: You will be primarily responsible for testing and validating multiple regulatory reports to ensure that they are prepared in ... Quality Assurance Unit is responsible for enhancing the integrity of the bank regulatory reporting processes, reporting data quality as well as the overall control… more
- Adecco US, Inc. (Clark, NJ)
- Adecco is currently assisting a local client in their search to fill a ** Regulatory Affairs Office Associate III** job opportunity located in **Clark, NJ 07066 ... in US and Canada as needed + Canada Chemical regulatory oversight and review + Preparing registration...Office Suite Apply Today to be considered for this ** Regulatory Affairs Office Associate III** job and… more
