- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be ... of labeling documents according to internal SOPs and external regulatory requirements.Prepare submission-ready labeling documents; Maintain and track … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Aequor (Hicksville, OH)
- …to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work ... safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and… more
- Gilead Sciences, Inc. (San Mateo, CA)
- … agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic ... products and indications. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.… more
- Bausch Health (Bridgewater, NJ)
- …policies and guidance and correctly apply them as appropriate in product development and labeling regulatory Regulatory Affairs Certification by RAPS a plus ... Associate Director, Regulatory Affairs Job Location:...management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses Ability to… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our San ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical and economic decision-making to help transform… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of… more
- Katalyst HealthCares and Life Sciences (Skaneateles Falls, NY)
- …proofread regulatory documentation. ssist in preparation and review of labeling , SOP s, and other departmental documents. Compile under supervision regulatory ... responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports… more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will ... labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …work in our office three days per week on average. Position Summary: The Associate Director (AD), Clinical Trial Materials (CTM) plays a pivotal role in the success ... clinical supplies - from demand forecasting and production scheduling to labeling , packaging, distribution, and inventory reconciliation. The AD, CTM works… more
- Thermo Fisher Scientific (Newport, KY)
- …and quality to deliver groundbreaking innovations. Discover Impactful Work: As an Associate Sample Coordinator, you will perform duties and training to acquire the ... a variety of simple inventory tracking procedures (receipt, check-in, login, labeling , inventory, transport, check-out, etc.) and administrative tasks in support of… more
- Winn-Dixie Retail Stores (Haines City, FL)
- …full, authentic selves. Read our Belonging, Inclusion and Diversity Statement here. Bakery Associate Job Purpose Job Summary Assists in the daily operations of the ... handling practices, sanitation and productivity are maintained. Adheres to all regulatory compliance requirements pertaining to food safety, United States Department… more
- City Winery (Boston, MA)
- …ensure proper completion of administrative duties by Shift Supervisors including logging, labeling , associate related forms including PTO requests, PAFs, CAFs, ... quality, freshness, and presentation, and maintaining compliance with all associated regulatory guidelines. This individual will be a creative thought leader with… more
- Marathon Health (Houston, MN)
- …MA, LPN, RN). Function to comply with state medical and nursing regulatory boards through signed protocols and procedures. Follows established departmental policies, ... appropriate. Review and audits clinical charts for quality assurance and regulatory compliances. Ensures confidentiality and handling procedures are followed for… more
- Stanley Black & Decker (Allentown, PA)
- …to air quality, hazardous waste, stormwater, and wastewater that meet regulatory requirements and company policies and procedures. Collect, analyze and report ... and waste data into the company's database. Prepare and submit required regulatory reports, including Air, EPCRA, Water, and Waste reports. Maintain compliance with… more
- KA Recruiting, Inc. (Houston, TX)
- …mounting (paraffin/frozen sections), staining (routine/special/IHC), slide and block labeling & coverslipping Performs special staining techniques for interstitial ... complex diagnosis and prognostic markers Contribute to corporate strategy for additional regulatory approvals (CAP, FDA, ) relating to GHI Histopathology Assess the… more
- MLee Healthcare Staffing and Recruiting, Inc (Lincroft, NJ)
- …reliability of test results. Prepare specimens for examination, ensuring proper labeling and documentation. Analyze test results and communicate findings to ... providers. Maintain and update laboratory records and ensure compliance with regulatory requirements. Assist in quality control and quality assurance procedures to… more
- BioSpace (Long Beach, CA)
- …treatment. Regularly communicate progress with SAM/ASD. Promotes KRYSTEXXA within approved labeling in a comprehensive, fair, and ethical manner that is consistent ... with industry specific and corporate legal and regulatory guidelines. Develops strong customer relationships by better understanding the customers needs and goals… more
- Winn-Dixie Retail Stores (Longwood, FL)
- …handling practices, sanitation and productivity are maintained. Adheres to all regulatory compliance requirements pertaining to food safety, United States Department ... of Agriculture (USDA) & Country of Origin Labeling (COOL), and Department of Agriculture (DOA). Executes all product recalls and withdrawals in a timely manner while… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is...function. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements, particularly US and EU.… more
