- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA -CMC leaders to formulate regulatory strategies for post-approval… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional ... RMAT, etc.)Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory … more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC ( RA CMC) leadership and strategy to achieve regulatory ... guidelines and industry standard methodologies to ensure the company's RA CMC activities are aligned with regulatory ...company's RA CMC activities are aligned with regulatory expectations.Lead and mentor a team of CMC professionals,… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Tris Pharma (Monmouth Junction, NJ)
- …manages prior art searches for targeted technologies or productsPartners with R&D and Regulatory Affairs departments for preparation of Orange Book listings and ... functions and new product development processes (ie, Compliance, R&D, Product Development, Regulatory Affairs , Government Affairs , etc.)Ability to influence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Create job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs Maintain training assignments ... field 7+ years of experience in pharmaceutical training, clinical research, or regulatory affairs Strong knowledge of clinical research processes, Good Clinical… more
- Merck & Co. (North Wales, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... management. In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch risk mitigation… more
- Aequor (New York, NY)
- …and Value, , Inc. Role Summary This is a full-time 12-month Contractor/Research Associate ( RA ) position in the HTA, Value & Evidence (HV&E) Global Access and Value ... Thoracic & Precision Medicine Oncology team. The RA will report to a member of the HV&E...at Headquarters in New York City. Role Responsibilities The RA is expected to provide technical support, analysis, and… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and cross-functionally to develop strategy relating to IME and External… more
- Cipla (Fall River, MA)
- …preference in pharmaceutical. Knowledge and experience in handling QC systems, LIMS, QA/R&D/ RA applications Experience with Quality, R&D, RA IT solutions ... infrastructure solutions etc., Experience supporting Quality - QC/QA, R&D and RA software solutions, IT infrastructure solutions etc., Has strong interpersonal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions With direction from ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... documnetation are accurate, accessible, and compliant wiht company and regulatory standards.This position also assists in tracking maintenance schedules, logging… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred 7+ years of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of PV … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree in a related field is preferred 10+ years of experience in pharmaceutical, regulatory affairs , or compliance roles, with a strong background in patient ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
