- 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 Strategy is responsible for leading the development and implementation… 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 ... s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical...decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and has strong… 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 ... team and serves as ad hoc member to the Global Project Team for late stage projects. This position...working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in… more
- Genmab A/S (Princeton, NJ)
- … Global Regulatory Lead, plan, prepare and lead FDA meetings as relevant. Support global regulatory lead and labeling strategy lead in development of the ... you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy...ensure optimal regulatory success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch… more
- BioSpace (Indianapolis, IN)
- …including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support ... strategies, development plans and study protocol design. Contribute to business unit and global alignment of clinical strategy and clinical plans. Understand and… 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 Strategy is responsible for leading the development and implementation… 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 Strategy is responsible for leading the development, maintenance, and… 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 ... Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and career interests. + Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications. + Oversees and guides ... and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global... Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical… more
- AbbVie (North Chicago, IL)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the… more
- Otsuka America Pharmaceutical Inc. (Little Rock, AR)
- …: Reporting to the Vice President, Global Medical Affairs, the Executive Director , CNS Strategy , Global Medical Affairs is a leadership position ... leads across functions, they will ensure a CNS portfolio Global Medical strategy is in place, including...space + Provides input into regulatory documents, including product labeling + Accountable for resourcing of personnel and budget… more
- Lundbeck (Deerfield, IL)
- …+ Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + Knowledge of development and registration ... Director US Regulatory Global Strategic Labelling...development, regulatory submission and launch. + Supports Lundbeck Product Labeling Committee activities, coordinating and collaborating with Global… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear and… more
- Lilly (Indianapolis, IN)
- …Sr. Director -Medical maintains close contact with relevant local and global clinical research management, marketing management, and corporate teams. In the ... regulatory purposes meets all necessary regulatory standards. + Provide support for global registrations, labeling and label modifications, and resolution of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading clinical...who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on… more
- BeOne Medicines (San Mateo, CA)
- …sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...regulatory issues and to expedite approvals of product and labeling changes. + Maintains awareness of global … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director Global Clinical Compliance builds, collaborates and manages key relations to better support and understand the ... of GMP and GDP compliance matters. This role reports to the Senior Director , Global Clinical Operations Compliance Lead. **Essential Functions of the Job:**… more
- AbbVie (Mettawa, IL)
- …inform COA measurement strategy for clinical trials and interfaces with external global regulatory [e.g. FDA, EMA etc.] to support labeling negotiations. + ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director works independently with guidance from a Director and is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …projects to lead, manage and oversee simultaneously. You will define the regulatory 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 oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding… more
- BeOne Medicines (Emeryville, CA)
- …draft papers + Contributes to and promotes the development of a global Pharmacoepidemiology (PE) strategy **Compliance, Standards, Training & Project** ... The Executive Medical Director serves as the Lead Product Safety Physician...multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With… more
