- 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
- Merck & Co. (Rahway, NJ)
- … Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory Affairs & Clinical ... and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head… 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
- 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
- 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
- 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
- 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)
- …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
- Merck & Co. (North Wales, PA)
- …experienced, motivated, and passionate commercial talent to serve as the Executive Director , US Commercial Leader, for our Ulcerative Colitis Indication within our ... for the US Market and our company.This role will lead the US Launch Strategy and readiness for our...key stakeholders across the enterprise, including Medical Affairs, Manufacturing, Global Marketing, Global digital data and analytics,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we work together to change lives for the better. The Position The Director , Media Relations & Issues Management is accountable for establishing and leading Novo ... to dramatically influence stakeholder perceptions. Relationships Reports to the Senior Director , Media & Stakeholder Relations, and interacts with senior leaders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy.- Construct and co- lead Advisory Panels at certain scientific conferences. Lead the Translational Subteam within the Global Project Team for the ... 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including… more
- Merck & Co. (Rahway, NJ)
- …Continuity Planning (BCP), including identification & prioritization of mitigation strategies. Lead Global Filing and Launch (GFLS) strategy development to ... manufacturing operations, technology, quality, and supply chain.- Proven ability to lead global , cross-functional teams through complex strategy/ project… more
- Merck & Co. (Rahway, NJ)
- …leading and growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and industry standards.Strong ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Regional Business Director will help recruit, hire, develop, and lead his/her sales team in solid ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… 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 ... and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory...tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & Compliance ... activities, managing in-house efforts and third-party vendor engagements. The Associate Director will also play a critical role in advancing the department's… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and...execution of overall packaging strate g ies that meet global network needs. Responsibilities include ensuring packaging system design… more
