- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- ProMedica Health System (Toledo, OH)
- REPORTING RELATIONSHIPS/SUPERVISORY RESPONSIBILITIES The Director of Medication Safety, Quality, and Regulatory Compliance will supervise system-wide initiatives ... responsible for medication safety, patient safety, quality improvement efforts, and regulatory compliance. POSITION SUMMARY The Director of Medication Safety,… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... Externally, the individual will interface with business partners regarding global development, regulatory , and registration strategies. + The Director , Global … more
- Takeda Pharmaceuticals (Boston, MA)
- …the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, execute ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ensuring ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties...degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for developing and implementing global ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… 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 ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug ...and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven… more
- Wells Fargo (Charlotte, NC)
- **About this role:** We are seeking a dynamic and strategic Regulatory Inventory Director to lead the governance and execution of the firm's regulatory ... servant leadership style, and the ability to represent the firm in regulatory exams and industry engagements. **Key Responsibilities:** **Compliance & Regulatory … more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... report to the Head of Regulatory Affairs and will oversee and/or manage CMC ...leading to successful preparation and approval of Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), … more