- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the ... Senior Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for… more
- NJEDA (Newark, NJ)
- …Staff, Managing Director - Policy, Research, and Government Affairs , and Director - Legislative & Regulatory Affairs to develop positions and ... contributes to bill comments prepared by the Legislative & Regulatory Affairs team on proposed legislation that...Senior Legislative Officer will report into the Managing Director - Policy, Research, and Government Affairs ,… more
- Mount Sinai Health System (New York, NY)
- …CMO - MSH, Mount Sinai Hospital **Responsibilities** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs ... **Job Description** A member of MSHS regulatory team, the Accreditation Specialist is a key...leader and participant in the systems continuous accreditation and regulatory readiness program. Responsible for providing direction and oversight… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This role leads ... The Senior Medical Director , Clinical Development will...advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision Medicine,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the assigned ... with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for ... assigned biological products in accordance with global regulations, guidance's and defined regulatory strategies. The Senior Scientist is responsible for the… more
- LS Power Development, LLC (East Brunswick, NJ)
- …parental leave and more. **About the Role:** We currently have an opportunity for a Manager/ Director of Government Affairs that can be based in our New Jersey or ... and advocacy strategies.As a member of LS Power's government affairs team, you will be responsible for designing and...are clearly aligned with business + Communicate legislative and regulatory strategies clearly to senior and executive… more
- City National Bank (New York, NY)
- * DIRECTOR BUSINESS AFFAIRS * *WHAT IS THE OPPORTUNITY?* This position provides overall management of significant City National Rochdale (CNR) projects on a ... onboarding, reviews, audits, and CNB issued remediation plans. * Reporting to Senior Managing Director Client Service/Operations. Lead Client Service and… more
- Merck (Rahway, NJ)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... product withdrawal. + Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of… more
- Merck (Rahway, NJ)
- **Job Description** The ** Senior Clinical Director ( Sr . Principal Scientist)** has primary responsibility for the strategic planning and directing clinical ... execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating… more
- JPMorgan Chase (New York, NY)
- …years' experience at a large financial institution, regulator or law firm leading regulatory affairs and/or engagements. + BA/BS or similar degree required. + ... status quo and striving to be best-in-class. As the Regulatory Strategy Director "RSD" for Asset &...team and for providing strategic advice and direction to senior LOB/function leaders concerning regulatory matters. This… more
- Danaher Corporation (New York, NY)
- …lives with diagnostic tools that address the world's biggest health challenges. The Senior Director of Medical Safety and Compliance will lead the Medical ... Safety & Compliance team, ensuring that Medical & Scientific Affairs are strategically positioned to provide timely medical and clinical consultation and review for… more
- Merck (Rahway, NJ)
- …under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations ... Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS), and QA… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director , HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and ... drug designation, diversity plans, etc.) * Working cross-functionally with medical affairs , clinical development, regulatory affairs , pharmacoepidemiology *… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This Senior Director , Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with ... of the business, including headquarters and field-based Commercial and Medical Affairs teams. This individual will integrate practical compliance best practices… more
- AbbVie (Jersey City, NJ)
- …The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to ... will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs. Responsibilities: + Understanding and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with leadership within Biostatistics and Data Management, Clinical Sciences, Regulatory Affairs , Development Operations and Development Program Management, ... The Executive Director , Biostatistics (CDU-Biostatistics Head, Internal Medicine) leads the...the development programs within the CDU, from pre-IPA through regulatory approval and post-marketing, and builds and empowers teams… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …a new formulation, or a specific development phase), under leadership of Program Lead Medical Director (Program Lead MD) or Sr . Medical Director . As a ... The Medical Director , Clinical Sciences functions as clinical leader of...Clinical Operations associates. + Supports Program Lead MD (and/or Sr . MD) and frequently lead interactions with external collaborators… more
- Danaher Corporation (New York, NY)
- …be a part of the Medical and Scientific Affairs team and report to the Senior Director , Medical and Scientific Affairs . If you thrive in a role utilizing ... diagnostic tools that address the world's biggest health challenges. The Medical Director , Scientific and Medical Affairs position for Beckman Coulter… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...BD while informing the broader scientific strategy with Medical Affairs . This role is accountable for de-risking the new… more