- Sanofi (Cambridge, MA)
- …Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical ... to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional… more
- Takeda Pharmaceutical (Social Circle, GA)
- …as applicable. Participate and work with project team members (Engineering, Manufacturing, Regulatory Affairs , Quality Operations , Quality Validation, Supply ... work in close cooperation with the manufacturing departments, Engineering, Regulatory , QC, and Quality Operations on a...resolution Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we… more
- Boehringer Ingelheim (Duluth, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The primary focus of the RA US Operations Excellence Partner is to partner with ... GI Region, USA CMC, Corporate Affairs or regulatory agencies. + In partnership with RA ...+ Must be legally authorized to work in the United States without restriction. + Must be… more
- Evident Scientific (Needham, MA)
- …& Global Collaboration** + Lead coordination between Clinical Affairs , US regulatory operations , and Global RA teams to ensure consistent ... excellence across global and regional projects. **Key Responsibilities** ** Regulatory Affairs ( US Focus)** +...and manufacturing centers in Japan, the United States , Germany, and China, with operations and… more
- Teleflex (Morrisville, NC)
- Sr Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic,...cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on supporting… more
- Teleflex (Wyomissing, PA)
- …technology solutions that make a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs ( RA ) Associate will be responsible for a ... RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada...and amendments. * Prepare electronic submission compilations for the United States ( US ), Canada, and… more
- Boehringer Ingelheim (Athens, GA)
- …employees. The Director, US Regulatory Affairs Pharmaceuticals leads the US Regulatory Affairs ( RA ) Pre and Post approval organization ... in accordance with company priorities and governance. The Director, US Regulatory Affairs Pharmaceuticals is...+ Must be legally authorized to work in the United States without restriction. + Must be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... chemistry or a related scientific discipline is strongly preferred. + Experience in regulatory operations , strategic planning, and operational execution of CMC … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... field. + 5-7 years of experience in pharmaceutical quality, operations , or business excellence roles. + Solid...are hired in the role to perform in the United States . Other elements may be used… more
- Astellas Pharma (Northbrook, IL)
- …an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will ... position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing...regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other… more
