- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation...other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy,… more
- Parexel (Austin, TX)
- …and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge ... to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as...Market Access teams to assess and mitigate impacts of regulatory changes. * Act as the primary RA… more
- ThermoFisher Scientific (Austin, TX)
- …Information** This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following ... regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing… more
- Sumitomo Pharma (Austin, TX)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... with but not limited to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and… more
- Oracle (Austin, TX)
- …To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing ... and public policies across the globe. In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's… more
- GRAIL (Austin, TX)
- …products 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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC- RA , labeling,...the global regulatory team (GRL, regional leads, CMC- RA , labeling, medical writing, regulatory operations, etc.)… more
- Sumitomo Pharma (Austin, TX)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...Global Regulatory Affairs (GRA) team based in the US. He/She will...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Pedernales Electric Cooperative (Cedar Park, TX)
- Regulatory Affairs Manager - CP Cedar Park, TX, US, 78613 PHYSICAL OFFICE LOCATION: , Cedar Park, TX 78613 Hybrid Work Options Available; This position can ... is responsible for supporting strategies and operations of the organization's regulatory affairs function, which ensures compliance with governmental regulations… more
- Parexel (Austin, TX)
- We are seeking a motivated **Senior / Regulatory Affairs Consultant - Advertising & Promotion** to join Parexel and work as a trusted partner within a major ... Qualifications * Education: Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs , or related field. Experience: * 3-5 years of pharmaceutical/biotech… more