- IQVIA (Durham, NC)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the enhanced… more
- Sumitomo Pharma (Raleigh, NC)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Kelly Services (Winston Salem, NC)
- …to support regulatory filings. + Ensure that all documentation aligns with regulatory standards ( FDA , EMA, ICH) and internal SOPs. + Assist in preparing ... development, manufacturing, or process development. + Experience with global regulatory filings and knowledge of FDA , EMA,...with global regulatory filings and knowledge of FDA , EMA, and ICH guidance. + Exceptional written and… more
- J&J Family of Companies (Wilson, NC)
- …efforts. + Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of ... to thrive in a multi-cultural and matrixed environment. + Knowledge of FDA /EMEA regulatory requirements related to biologics and/or pharmaceuticals, preferred. +… more
- IQVIA (Durham, NC)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- US Tech Solutions (Wilson, NC)
- …role within the biological and/or pharmaceutical industry + Knowledgeable of FDA /EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ... + Pharma background, helpful + Must have knowledge of FDA / EMEA regulatory documentation **Education:** + Bachelor's degree in a scientific, engineering,… more
- Cardinal Health (Raleigh, NC)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …Skills and Abilities:** + Strong knowledge of Food and Drug Administration ( FDA ) regulatory requirements for good manufacturing practices. + Demonstrated ... reviewed, justified, documented, approved, and implemented in conformance with regulatory requirements and company policies / procedures. **Primary Responsibilities:**… more
- US Foods (Lexington, NC)
- …the lowest unit cost and manages staff to ensure the integrity, USDA / FDA regulatory compliance, sanitation, shipping receiving and inventory control. **We help ... deadlines and quality specifications are met in accordance with internal and regulatory guidelines * Establishes and maintains cross functional relationships in a… more
- AbbVie (Raleigh, NC)
- …ability to present didactic and hands-on content in small groups + Knowledge of FDA and regulatory statutes as applied to Allergan Aesthetics products, with the ... ability to function in an environment controlled by outside regulatory entities + Classroom training experience on procedure training, consultation, business-to… more