- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems. Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …new ways to solve problems. Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and ... via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of… more
- CSL Behring (King Of Prussia, PA)
- …serious and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our King of ... will contribute to the vision, goals and improvement of Global Regulatory Affairs and includes...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Teva Pharmaceuticals (West Chester, PA)
- …biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure ... will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in...applications and product life cycle management submissions with the Global Regulatory Affairs Team from… more
- Merck (North Wales, PA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Teva Pharmaceuticals (West Chester, PA)
- …difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help ... Senior Director Regulatory Affairs CMC (Biologic Products) Date:...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- Teva Pharmaceuticals (West Chester, PA)
- …in Global Regulatory Operations management team meetings. + Leads major Global Regulatory Affairs project teams. + Develop functional SOPs as well ... meet company goals. Has the ability to inspire and lead teams to fullest potential in a positive approach...Stock Purchase Plan and Tuition Assistance. **Reports To** VP Global Regulatory Affairs **Already Working… more
- Pfizer (Collegeville, PA)
- …(CMC) regulatory strategies for small and/or large molecules to meet global regulatory requirements throughout the life cycle. You will participate in ... of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other...global internal partners, ie, Research and Development, Pfizer Global Supply, Global Regulatory Sciences,… more
- CSL Behring (King Of Prussia, PA)
- …after commercialization. + Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input ... Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in...with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) ( Global … more
- Philips (Malvern, PA)
- …for innovative solutions in all target markets. **Your role:** + _Plan, generate, and lead global regulatory strategy for wearable devices, Software as a ... Intelligence (US Hub Based)** The Principal Regulatory Affairs Specialist- SW & AI will shape, lead...globally. You will work closely with various stakeholders from global Philips Innovation Hubs, and regulatory leaders… more
- J&J Family of Companies (Spring House, PA)
- …compounds and compounds in clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and partner closely with ... areas. Be an active member of the CDT and lead a Global Medical Affairs ...Excellent knowledge of study execution, benefit risk management and regulatory affairs . + Proven ability to act… more
- J&J Family of Companies (Horsham, PA)
- …with the global functions including clinical R&D, translational medicine, regulatory affairs /labelling, and global medical safety. This includes ... Senior Director, Strategic Lead US Medical Affairs Gastroenterology -...ensure the strategy is aligned and successfully executed across global medical affairs , GI MSL, publications, marketing,… more
- J&J Family of Companies (Horsham, PA)
- …skills and the ability to influence is necessary * Experience interacting with global regulatory authorities is also desirable * Approximately 20% travel ... portfolio of IMM products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs , Real-world Value & Evidence, Biostatistics, and work… more
- J&J Family of Companies (Horsham, PA)
- …skills and the ability to influence is necessary * Experience interacting with global regulatory authorities is also desirable * Approximately 20% travel ... portfolio of IMM products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs , Real-world Value & Evidence, Biostatistics, and work… more
- Merck (Upper Gwynedd, PA)
- …in key health systems accounts + Serves as a resource for the HSO MAD Team Lead , HSO Executive Director Medical Affairs , and other members of Country Medical ... **Job Description** Our Medical Affairs team advances patient care by engaging in...in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also… more
- Merck (North Wales, PA)
- …of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation ... product withdrawal. + Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of… more
- Pfizer (Collegeville, PA)
- …in Inflammation and Immunology specific therapeutic areas + Demonstrated ability to develop, lead and execute global medical affairs strategies and tactics, ... effectively benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead...Medical Director - Abrocitinib Team Lead will lead a team of medical affairs colleagues… more
- Organon & Co. (Plymouth Meeting, PA)
- …products through the product lifecycle. + Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of ... CMC changes, identification of global regulatory requirements, and critical evaluation of...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Pfizer (Collegeville, PA)
- The Global Clinical Lead is a leadership role that represents clinical development on the Medicine Team as the single point of accountability for clinical ... assets for heart failure and other cardiovascular indications. + Leads the Global Clinical Team towards the common goal of approvable worldwide regulatory… more
