- Catalent Pharma Solutions (IN)
- **Position Title: Director , Regulatory Affairs ** **Location: Field-Bloomington, IN or Harmans, MD** **Summary:** Reporting to the VP, Global Regulatory ... Affairs & Compliance, the Director , Regulatory Affairs is accountable for the direct management and guidance regarding the organization's cGMP compliance… more
- ICON Clinical Research (Indianapolis, IN)
- ** Director , Regulatory Affairs ** Location: Any location in the US. Remote or Office based. Due to a number of exciting new projects being awarded to ICON, we ... are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs within our US team. We are looking for passionate,… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …be empowered to take charge of your future at Takeda. Join us as a Senior Director , Global Regulatory Affairs , GI - Hybrid. Here, everyone matters and you ... bold mission. As a Senior Director working on the Global Regulatory Affairs GI team, you will be empowered to provide leadership and development to… more
- Cook Medical (West Lafayette, IN)
- Overview The Director of Regulatory Affairs provides the primary management function, leadership, and direction for regulatory affairs across Cook ... and Cook Biotech Quality System. Responsibilities Personnel* Provide leadership to the Regulatory Affairs team with attention to corporate goals, policies,… more
- Bausch Health (Merrillville, IN)
- …and effective aesthetic care options to consumers and physicians alike. The Head of Regulatory Affairs - Solta has the unique opportunity to lead strategy ... development & execution, and post-approval activities for the Global Regulatory Affairs organization. This role oversees the development of regulatory … more
- Merck (Indianapolis, IN)
- …+ Action oriented with strong cross-functional collaboration skills Strategic Summary: Our Regulatory Affairs team bring new medical advancements to the world ... **Job Description** The Associate Director within Advertising and Promotion reports to the...colleagues to ensure that promotional practices are consistent with regulatory guidelines, company policies, and support business objectives. **Key… more
- American Water (Greenwood, IN)
- …State President and indirectly to the Vice President National Government and Regulatory Affairs . This role interfaces and aligns government relations activities ... State Government departments (ie, Environmental Regulations, Public Utility Regulations, etc. The Director of Government and Consumer Affairs reports directly to… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Management portfolio and associated information repositories serving the Global Regulatory Affairs organization and business processes. Incumbent will ... life-changing therapies to patients worldwide. Join Takeda as a Director , of Regulatory Information Management, GRA where...to solutions and information for the needs of Global Regulatory Affairs . + Ensure Takeda portfolio support… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …where you will be a strategic collaborator and thought partner to the Global Regulatory Affairs (GRA) Therapeutic Area Unit (TAU) Heads. Works closely with TAU ... therapies to patients worldwide. Join Takeda as an Executive Director , Head of Global Regulatory Project Management...+ Strategic collaborator and thought partner to the Global Regulatory Affairs (GRA) Therapeutic Area Unit (TAU)… more
- Lilly (Indianapolis, IN)
- …and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers + Engage in forums that share ... efficiency in drug development. The purpose of the Senior Director - Global Regulatory Policy (Immunology Business...dotted line reporting relationship to Associate Vice President, Global Regulatory Affairs , IMBU + Position Location -… more
- Pfizer (Indianapolis, IN)
- **ROLE SUMMARY** The Senior Director Regulatory Intelligence and Quality Standards reporting to the VP, Operations Compliance Readiness, is responsible for ... create the necessary Quality Standards, ie Policies and Procedures. The Senior Director Regulatory Intelligence and Quality Standards interfaces with senior… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project ... yrs in regulatory + Advanced education or credentialing in regulatory affairs and project management preferred + Demonstrated expert experience leading high… more
- Pfizer (Indianapolis, IN)
- …potentially regulatory meetings. + Represents Vaccine & Anti-viras Clinical Affairs and may take the lead on company-wide, global process improvement ... is the point person for the product in Clinical Affairs . The CS Lead may have 1-4 direct reports/contractors...the product suite of observational study execution. This Sr. Director Lead CS will have 2-4 direct reports and… more
- Pfizer (Indianapolis, IN)
- …and discuss data at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents TA Clinical Affairs and may take the ... in a given Therapeutic Area (TA). In collaboration with Clinical Epidemiology/Scientific Affairs (SA), Medical Affairs (MA), Biostatistics and Clinical … more
- Pfizer (Indianapolis, IN)
- … Director Field Medical, MD/DO will represent Pfizer Medical Affairs with external MD-based professional associations and/or societies and contribute expertise ... **ROLE SUMMARY** The Field Medical Director is a field-based medical colleague in the...provide therapeutic area/product expertise for regional and other Medical Affairs and/or clinical development needs as approved by FM… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …cross-functional initiatives and influence the field as applicable as part of the Global Regulatory Affairs team. You will report to the Head of Global Labeling ... labeling, and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices. + Project management abilities. +… more
- J&J Family of Companies (Indianapolis, IN)
- …Other functional groups represented on the team include project management, regulatory affairs , global clinical operations, data management, medical writing, ... and new ideas to assist in identifying new research opportunities. The Medical Director /Senior Medical Director supports medical affairs activities involving… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …(preferably including pharmaceutical industry functions such as Marketing, Sales, Discovery, Regulatory Affairs , Clinical, Legal, etc. + Strong interpersonal ... US Oncology Field Medical, you will report to Senior Director Field Medical, support the Colorectal Cancer (CRC)Franchise, and...PharmD, or DNP) + Minimum of 7 years Medical Affairs experience, with 4+ years Field Medical experience +… more
- J&J Family of Companies (Indianapolis, IN)
- …to treatment and support the interpretation and reporting of results. + Assist Regulatory Affairs in determining requirements for any corrective actions or ... Associate Director , Clinical Project Scientist (1 of 3) -...in conjunction with other clinical team members. + Assist Regulatory Affairs in the development of drug… more
- Edwards Lifesciences (Indianapolis, IN)
- …company, specifically but not limited to Operations, Finance, Marketing, Human Resources, R&D, Regulatory Affairs , Medical Affairs , and Clinical Affairs ... Regional Sales Director , [North Region] - Transcatheter Mitral and Tricuspid...of competitive business strategies and product pipeline, healthcare economics, regulatory and legislative activities and incorporate into regional sales… more