- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs , Regulatory Strategy to be a part of our ... Global Regulatory Affairs organization.In this role, you will...new indications. You will act as contact person with FDA and provide regulatory expertise and guidance… more
- Genmab (Plainsboro, NJ)
- … Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (eg FDA , EMA) A broad knowledge of life-cycle ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the...regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …relating to compliance efficiently and with utmost professionalism. The Director of Regulatory Affairs will also interact with many consultants, Exela's contract ... submission of regulatory dossiers. The Director of Regulatory Affairs will participate in discussions on...clinical trial work, in multiple jurisdictions, specifically with FDA , EU, and MHRA. Have strong working knowledge of… more
- Merck & Co. (North Wales, PA)
- …history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department...and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in developing, implementing/facilitating, maintaining technical training programs related to GxP, Clinical , Medical and Regulatory affairs , Patient Safety ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Merck & Co. (Rahway, NJ)
- …trials, safety monitoring, analysis of data and communication of study findings. (b) Global Regulatory Affairs and Clinical Safety: Focus on late-stage and ... working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals. -...may be opportunity to rotate to another area in Clinical Drug Development or Global Medical/Scientific Affairs … more
- Merck & Co. (Rahway, NJ)
- …such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of ... of clinical research and clinical trial methodologies.Strong regulatory knowledge, including FDA /CVM, EMA/CVMP, and VICH guidelines.Excellent strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical , Medical and Regulatory (CMR) department...the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing… more
- Insmed Incorporated (San Diego, CA)
- … clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, ... of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%#LI-MM1Travel… more
- Tris Pharma (Monmouth Junction, NJ)
- …working knowledge of regulatory and industry standards related to Medical Affairs role including Food and Drug Administration ( FDA ), Office of Inspector ... for scientific exchange with prioritized stakeholders in support of Medical Affairs strategiesCoordinates MSL support for clinical activities and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Evident Scientific (PA)
- …discussions with the FDA . This position requires a strong background in regulatory affairs , clinical trial management, and a comprehensive understanding ... Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs Job...of FDA and global regulatory pathways for medical devices and IVDs. ** Clinical … more
- Kelly Services (Philadelphia, PA)
- …consideration, please apply. Kelly(R) Science & Clinical is seeking a Clinical Research Regulatory Affairs Associate for temporary, temporary-to-hire, ... Overview: Our client is seeking a dedicated and detail-oriented Clinical Research Regulatory Affairs Associate... clinical research industry. * Strong knowledge of regulatory requirements and guidelines (eg, FDA , EMA).… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance to ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Cordis (Irvine, CA)
- …will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry. **Responsibilities** + Lead ... (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic...and procedures to enhance operational efficiency. + Help manage FDA IDE/PMA clinical reports/modules and post approval… more
