- Sanofi (Morristown, NJ)
- Job Title: Director , Global Regulatory Affairs - Global Labeling Strategy Location : Morristown, NJ or Cambridge, MA (Hybrid) About the Job Are you ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...on organizational structure. About You COMPETENCES Strong knowledge of global regulatory labeling requirements (FDA,… more
- Merck & Co. (Rahway, NJ)
- …Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global Labeling Business Users of the Systems and the associated ... remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling , System Support Team, IT and Learning & Development… more
- Genmab (NJ)
- …we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for leading ... Affairs (GRA) and will report to the Sr. Director , Labeling , Policy and Intelligence. The position... global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS… more
- Genmab A/S (Princeton, NJ)
- …fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of ... to ensure optimal regulatory success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and… more
- Ahold Delhaize USA (Woodbridge, VA)
- Ahold Delhaize USA, a division of global food retailer Ahold Delhaize, is part of the US family of brands, which includes five leading omnichannel grocery brands - ... through training, coaching, auditing and mentoring. Interact regularly with the regulatory arena as official liaison. Applicants must be currently authorized to… more
- BioSpace (Indianapolis, IN)
- …and labeling modifications in collaboration with affiliates, brand teams, regulatory , and legal. Provides medical expertise to regulatory scientists. ... efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. Participates in advisory… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... progress. The Associate Director , Global Regulatory Affairs - Global Labeling ... function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... accelerate progress. The Director , Global Regulatory Affairs - Global Labeling ...organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements (FDA,… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... You will provide strategic input and management oversight of regulatory labeling activities for multiple products across...new therapeutic areas. + Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- Merck (Rahway, NJ)
- …Enhancement and System Monitoring related initiatives. + Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT ... remain aligned with the current system version. Work collaboratively with stakeholders in Global Labeling , System Support Team, IT and Learning & Development… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global ...team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead… more
- AbbVie (North Chicago, IL)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead ... (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the...regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead ... authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- Chiesi (Cary, NC)
- …and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and ... changes to existing labeling , and submission of labeling information to regulatory authorities in the...regulatory compliance. Knowledge of Common Technical Document and global guidelines on content and format of labeling… more
- Lundbeck (Deerfield, IL)
- …requiring knowledge and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory ... Director Regulatory Affairs Alliance and Commercialization...publications, and trial engagement materials. + Provide directions to global labeling processes, including inform decisions on… more
