- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Millsboro, DE)
- …aseptic operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality… more
- Merck & Co. (North Wales, PA)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early/late-stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent requiredRelevant ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...years of experience managing direct reports. Competencies: Ability to lead in a highly collaborative global environment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs, Medical Analytics will be responsible ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… more
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product ... strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical experts responsible providing Center ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and… more
- Merck & Co. (Rahway, NJ)
- …along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a team ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics ... risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution… more
- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging… more
- Insmed Incorporated (NJ)
- …tactical execution tailored to each geography.Franchise CollaborationPartner closely with the Senior Director , HCP Marketing Lead (PAH) to ensure alignment and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP… more
- Merck & Co. (Durham, NC)
- …introduction, product source change and/or device component source changes.The incumbent will lead or support complex global and site-centric capital and ... supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate… more
- Eisai, Inc (Nutley, NJ)
- …5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead .A thorough understanding of global regulatory requirements on ... (DDP)Leads the development of Clinical Protocols to meet CDP objectives.Serves as Study Director /Clinical Pharmacology Lead and drives the execution of the study… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the product… more
- Insmed Incorporated (NJ)
- …Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, Advocacy, and Commercial Operations team ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib… more
