- 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 (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
- 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
- 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
- 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
- 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
- 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)
- …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
- Valvoline Global (Lexington, KY)
- …operations. This includes oversight of executive protection, facility security, global travel risk management, regulatory compliance, crisis response, ... + Conduct threat vulnerability assessments specific to executive visibility and event exposure. ** Global Travel Risk Management** + Lead a global travel… 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)
- …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
- BeOne Medicines (San Mateo, CA)
- …is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. ... **General** **Description:** The Director , Regulatory Affairs, Dx/CDx and Medical...development plans. + Act as the representative of European regulatory team at the global regulatory… more
- BeOne Medicines (San Mateo, CA)
- …for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage ... **General Description:** The Director , Regulatory Affairs will be responsible...the global strategy as determined by the global regulatory leader. + Reviews sections of… 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
- BeOne Medicines (Emeryville, CA)
- …labeling as part of the Labeling Working Group. + Serve as the lead regulatory representative on various cross-functional teams, including promotional and ... **General Description:** This role is the head of Promotional Regulatory , and provides regulatory leadership, support, oversight, and strategic guidance on… more
- ALBEMARLE (Charlotte, NC)
- …& EMEA, with indirect reports in Australia & Chile. Procurement & Contracting + Lead global tender events (RFI, RFP, RFQ) for logistics services including ... ourselves, our customers and the planet. **Job Description** **SUMMARY** The Director , Global Logistics Procurement and Enterprise Procurement Risk Management… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....for the execution (in conjunction with the TMED Operations Lead ) and reporting thereof. The Director will… 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
- BeOne Medicines (San Mateo, CA)
- …As the Director , Global Commercial, Sonrotoclax, you will lead global initiatives related to professional promotion, omnichannel planning, competitive ... and local cross-functional teams and report to the Executive Director , Global Commercial Lead , Sonrotoclax....events and market dynamics. + Partner with Medical Affairs, Regulatory , Access, and marketing teams to craft responsive and… more
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