- BeOne Medicines (San Mateo, CA)
- …with applicable regulatory requirements and guidelines, and consistency with approved labeling . The role also is expected to work closely with our in-house ... the Labeling Working Group. + Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees.… more
- CSL Behring (King Of Prussia, PA)
- …a hybrid position and is onsite three days a week. You will report to the Executive Director , Head, Global Labeling & Labeling Data Strategy. The ... a meaningful difference worldwide. Could you be our next Director , Global Advertising and Promotion? The job... oversight, leadership and direction to develop and execute global regulatory ad/promo strategies to support product… more
- BeOne Medicines (San Mateo, CA)
- …expedite approvals of product and labeling changes + Maintains awareness of global regulatory environment and assess impact of changes on business and ... **General Description:** The Director , Regulatory Affairs will be responsible...line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders.… more
- Lundbeck (Deerfield, IL)
- …and KOL relationships and collaborating with other functions (eg, Value Evidence, Regulatory , Clinical Development, Brand Teams, Global Medical Affairs etc.) in ... Associate Director Medical Affairs - Neurology Requisition ID: 7013...including late stage and pipeline products + Collaborate with global Medical Affairs and cross-functional teams ( Regulatory ,… more
- BeOne Medicines (San Mateo, CA)
- …+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- Organon & Co. (Jersey City, NJ)
- …, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of… more
- CSL Behring (King Of Prussia, PA)
- …and clinical expert in the assigned disease area. + Provide input on US labeling and regulatory strategy. + Maintain in-depth understanding of disease states, ... As the Senior Director , Medical Affairs, you will lead the development...Develop and execute annual US Medical plans based on global Medical strategies + Localize global Medical… more
- Revelyst (Irvine, CA)
- … laws and regulations. + Support product compliance team and legal submission of global mandatory reports to regulatory bodies when necessary. + Review marketing ... Golf and Foresight Sports. This position reports to the Director of Product Compliance and is based out of...manufacturing partners. + Staying aware of changes in the regulatory environment to minimize the impact to the business.… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will ... Stakeholder Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation… more
- ThermoFisher Scientific (Greenville, NC)
- …Document Specialist (GL&LDS) Team is responsible for managing global labeling activities and ensuring compliance with international regulatory standards. ... strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment. + Acts as a … more
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