- J&J Family of Companies (Spring House, PA)
- Senior Director , Global Regulatory Leader , CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... have a positive impact on their communities. The Senior Director , Global Regulatory Leader...strategy, regional strategies, CMC-RA strategy, and commercial strategy. + Lead the Global Regulatory Team… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Titusville, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Senior Director Regulatory Affairs CMC (Biologic Products)...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- Teva Pharmaceuticals (West Chester, PA)
- …making a difference, and new people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs, is a strategic role that will be ... Director , Regulatory Affairs, Strategy - Innovative Medicine...products. + As a global or regional lead within a global regulatory team,… more
- Pfizer (Collegeville, PA)
- …with other Regulatory Role(s) (ie regional EM or US lead and/or Global Regulatory Lead for other programs), Project(s) assigned can be in development ... for a Director to join our vaccines Global Regulatory Science team as a US...as regulatory representative to Global Regulatory Strategy Team (GRST). * Lead and… more
- Teva Pharmaceuticals (West Chester, PA)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Director will foster relationships with opinion ... (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input...Oversees the preparation of documents for IND/NDA and other regulatory documents + May lead an NDA… more
- J&J Family of Companies (Spring House, PA)
- Global Medical Affairs Leader , Director...clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and ... Global Medical Affairs, is recruiting for a Global Medical Affairs Leader (GMAL), Director...areas. Be an active member of the CDT and lead a Global Medical Affairs Team consisting… more
- J&J Family of Companies (Horsham, PA)
- …2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader in Raritan, NJ; ... Associate Director , Global Labeling Product Leader...a positive impact on their communities. **Key Responsibilities:** + Lead the development, revision, review, agreement, and maintenance of… more
- Teva Pharmaceuticals (West Chester, PA)
- …day** + Responsible to manage Product Submission Team and dossier timelines. + Accountable to Global Regulatory Lead and Global Regulatory Affairs, ... manage detailed regulatory project plans for major global dossiers. The Director that fills this...adaptations needed as challenges arise. + In collaboration with regulatory lead and project leader ,… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR...will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in ... strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to… more
- Teva Pharmaceuticals (West Chester, PA)
- …and timelines and serve as a liaison in stakeholder management. + Participate in Global Regulatory Operations management team meetings. + Leads major Global ... Senior Director , Regulatory Affairs II Date: Apr...Stock Purchase Plan and Tuition Assistance. **Reports To** VP Global Regulatory Affairs **Already Working @TEVA?** If… more
- Vanguard (Malvern, PA)
- …providing exceptional, high-value business partnership and compliance support. As a trusted leader , the Compliance Director , Regulatory Exam Response will ... Compliance Director , Regulatory Exam Response Advocate for...with purpose - and that's how we've become a global market leader . Here, we grow by… more
- Pfizer (Collegeville, PA)
- …for the development of therapies for multiple medicines in prostate cancer + Lead product specific Global Development Team + Oversee development for multiple ... program with the external clinical community. Principal Responsibilities: + Lead , develop and execute the strategic development of therapies...leader and a key contributor + Has a global perspective and mindset, with the ability to work… more
- Insight Global (Robbinsville, NJ)
- …closely with industry information sharing exchanges along with other government agencies. The global SOC is a 24x7x365 function. The leader ensure that SOC ... security ecosystem, close collaboration with IT operations and other community leader . The "role" will be accountable for Security Operations, Threat Intelligence,… more
- Pfizer (Collegeville, PA)
- **ROLE SUMMARY** + Reporting to the VP, Global Gastroenterology Medical Lead , the Senior Director , Gastroenterology (GI) and Biosimilars is an integral ... the GI GMAT and will work closely with the Global Medical Gastroenterology lead to develop the...the strategic GI medical plan across assets + The Global Senior Director , GI and Biosimilars… more
- J&J Family of Companies (Horsham, PA)
- …with the Compound Development Team (CDT) to provide commercial guidance into the global regulatory and clinical development plans to ensure early stage assets ... Director , Global Commercial Strategy, Dermatology -...not limited to, Hidradenitis Suppurativa and Alopecia Areata. + Lead the global team effort for insight… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… more
- Merck (North Wales, PA)
- …supporting the Disease Area Strategies for Melanoma. Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing - ... engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and… more
- Merck (West Point, PA)
- …creative conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. + Demonstrated experience ... a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule...TT teams. + Required to comply with our Company Global and regulatory requirements and execute current… more