- BeOne Medicines (Emeryville, CA)
- …will interface with outside regulatory agencies and more specifically, the FDA , and business partners regarding development, regulatory, and registration strategies ... risk assessments, critical issue management and advice for the FDA and Health Canada interactions. + Uses extensive knowledge...local regulatory requirements + Liaises and negotiates with the FDA and Health Canada as needed for all aspects… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …area of responsibility. 21. Strict adherence to procedures and practices according to FDA regulations. 22. Strong emphasis on documentation according to FDA ... experience maintaining automated manufacturing systems and equipment, preferably in an FDA / GMP regulated environment. Experience with robotics, PLCs, PLC networks,… more
- Quality Consulting Group (Juncos, PR)
- …respect to current corporate policies, industry standards, regulatory standards and FDA standards. + Evaluate and determine if utility systems, process maintenance, ... in compliance with all applicable industry standards, regulatory standards and FDA standards. + Participate in the coordination of TECHSUPPORT on engineering,… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical,...be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other… more
- WuXi AppTec (Middletown, DE)
- …of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and safety regulations. + Conducting ... drawings, and functional specifications. + Thorough understanding of cGMP and FDA requirements + Strong communication and documentation skills + Proven project… more
- Celestica (Maple Grove, MN)
- …customers, suppliers, and partners, and ensuring compliance with regulatory requirements ( FDA , ISO, ASQ, RAC). The position is virtual, offering competitive ... compensation and career growth opportunities. Significant experience with FDA certification processes is required. **Candidate Profile** The Director, Global Quality… more
- ITG Brands (NC)
- …strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health standards. Oversee and conduct human health ... a regulatory-facing subject matter expert, representing the company in FDA meetings, scientific conferences, and industry forums. Collaborate cross-functionally with… more
- Bristol Myers Squibb (Madison, NJ)
- …BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, ... compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with subpart E/H...for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion + Ensure monitoring… more
- Boehringer Ingelheim (Ridgefield, CT)
- …to successfully generate quality documents with internal customers and with FDA to achieve timely labeling reviews/approvals in alignment with business objectives. ... required labeling components for filing of required information to FDA , including eg, SPL, Artwork, Word files, and b)...Labeling Operations on local working groups. Labeling Submissions to FDA - + Prepares labeling documents needed for regulatory… more
- Stanford University (Stanford, CA)
- …generate reports and prepare documents for submission as required by the IRB, FDA , OSP and APB requirements, including annual reports, and IND safety reports. The ... Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will gather,...Review Board (IRB), United States Food and Drug Administration ( FDA ), Office of Science Policy (OSP) and APB (Biosafety… more