Senior Director of Regulatory Affairs

Sr. Director, Regualtory Affairs This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in...

Sr. Director, Regualtory Affairs This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in...

Sr. Director, Regualtory Affairs This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in...

Overview Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women's health. Our first Research and Development facility in the US is located...

Sr. Director, Regualtory Affairs This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in...

This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in New Jersy in Somerset county (No...

This is an induvidual contributor role.Small company experience is ideal.Experience negotiating / communicating with FDAExperience with submitting regulatory dossiers for reformulations of a currently approved product: includes information on: administrative information, quality, safety, and efficacy.This role is Hybrid in New Jersy in Somerset county (No...

Job Summary:Lupin Pharmaceuticals is seeking a highly skilled and experienced Executive Director, Legal Counsel, M&A to lead the strategic transactions function for our US Generics business. This role will be responsible for driving the strategic and business planning function, including ongoing assessment and forecasting of key assets, helping to de-risk...

Legend Biotech US is seeking a highly skilled and motivated Senior Clinical Trial Associate to join our dynamic and expanding Clinical Operations team.The ideal candidate will have substantial experience in clinical trial support and administration, demonstrating a deep understanding of clinical trial processes and regulatory requirements.This role is...

Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

Reporting to the Senior Director, Quality Assurance & Regulatory Affairs, the QMS Engineer will play a key role in managing the Quality Management System, Quality Engineering functions, internal and external audits, validation, and document control.Primary areas of responsibility include CAPA, NCR, change control, risk management, process review and approval...

Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

Job Title: Medical Records DirectorJob Summary:We are seeking a highly skilled Medical Records Director to lead our medical records department. The ideal candidate will have a strong background in medical records management and be able to develop and implement policies and procedures to ensure compliance with state and federal accrediting...

Job SummaryWe are seeking a highly skilled and experienced Director of Nursing to lead our Ambulatory Surgical Center team.The successful candidate will be responsible for overseeing the delivery of high-quality nursing care to patients, ensuring compliance with regulatory requirements, and promoting a culture of excellence within the organization.Key...

Description Director of Operations II, RWLP Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one...

Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance and practical...

About Syneos HealthSyneos Health is a leading global contract research organization (CRO) driving innovation in clinical development. Our mission is to deliver a rich and rewarding career experience to our employees.Estimated Salary: $180,000 - $250,000 per yearJob DescriptionJob SummaryThe Senior Vice President of Growth and Partnerships will lead the...

Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

Description Senior Medical Writer (Regulatory) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...