- Insmed Incorporated (NJ)
- …other, and 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 regulatory strategies and plans to enable...PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in … more
- Merck & Co. (Rahway, NJ)
- …required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The ... implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for electronic submissions… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Insmed Incorporated (NJ)
- …other, and 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...US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The ... Skills: Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …Skills: 10 years of experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs , medical and scientific ... Job DescriptionThe Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical quality, and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand… more
- Insmed Incorporated (NJ)
- …and QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA, ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document… more
- Merck & Co. (North Wales, PA)
- …of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... and Development Division, Value & Implementation Human Health, Manufacturing Division, IT Global Medical Proficiency and External Affairs (GMPEA) Global … more
- Lundbeck (North Hyde, SD)
- …would need to have the following qualifications: A Bachelor's degree in law, regulatory affairs , pharmacy, or related field. A legal practicing certificate is ... is currenting recruiting for a qualified Compliance and Legal Director to join our team. The role reports to...global collaborative outreach and the Compliance and Legal Director will be part of Lundbeck's Regional Compliance Officer… 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, ... functional impact metrics.Cross-functional Alignment - Partner across all of Medical Affairs , particularly with Global Medical Strategy, Regions, Field Medical,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... only - is not for those applying for a global assignment and/or for employees working outside of Cipla's...In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Boehringer Ingelheim (Ridgefield, CT)
- …lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team. The Director , Global Regulatory ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead...RA sub team / RET to accurately reflect global regulatory requirements and challenges in the… more
- Amgen (Washington, DC)
- …best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership,… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As Associate Director...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... global development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As ...of the global regulatory team. As Director , ...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
