- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA)...within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Sumitomo Pharma (Atlanta, GA)
- … Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function ... as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Boehringer Ingelheim (Athens, GA)
- …meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs ( RA ) core or subteam member in projects as well ... **Description** Manager The Manager, Regulatory Affairs ( RA ) Pharma...as defined. + Supports specific infrastructural projects as assigned. Associate Director + Responsibility for the safety… more
- GRAIL (Atlanta, GA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Boehringer Ingelheim (Duluth, GA)
- …basis with domestic and global trade associations. The Senior Associate Director of US Regulatory Affairs Animal Health Intelligence and External ... regard for our employees. The Senior Associate Director of US Regulatory Affairs ...Marketing, US Commercial Operations, Global and US Regulatory teams. The incumbent serves as RA … more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a...key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- The Associate Director of Regulatory ...+ Build professional network with key stakeholders outside of Global Regulatory Affairs to identify ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , RA Service Center will hold full accountability ... for the Regulatory Affairs ( RA ) US outsourcing...must bring advanced capabilities in: + Strategic Thinking: Translating regulatory complexity into actionable strategies that support global… more