- Syner-G BioPharma Group (Boston, MA)
- …cGxP Quality Systems within an FDA -regulated manufacturing company.Knowledge of FDA regulations and guidance or applicable regulatory standards and ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to...cGMP Manufacturing within an FDA -regulated manufacturing company.Knowledge of… more
- Takeda Pharmaceutical (Social Circle, GA)
- …Specialist, you will ensure all fractionation operations comply with corporate policies, regulatory requirements (GMP, FDA , EMEA), and safety practices. The ... presentations and supporting materials as needed. Ensure compliance with all regulatory requirements and internal standards within the manufacturing process. Follow… more
- Cipla (Hauppauge, NY)
- …Office, SAP, and other business applications. Strong knowledge of GMP, regulatory requirements ( FDA ), and pharmaceutical manufacturing processes. Prior ... experience in RX and generic pharmaceutical manufacturing/packaging is a plus. Effective interpersonal relationship skills and the ability to work in a team environment. Proficiency in the English language to include usage, spelling, grammar, and punctuation.… more
- Cipla (Hauppauge, NY)
- …and other packaging materials. Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper ... Outlook, PowerPoint) and other relevant inventory/warehouse management software. Familiarity with FDA labeling requirements and other regulatory standards for… more
- Cipla (Fall River, MA)
- …and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA , ). Maintain and ensure the proper documentation ... requirements. Ensure that the company remains compliant with all regulatory requirements (eg, FDA , ICH, EMA). Support risk assessments and help mitigate any… more
- MCKESSON (Richmond, VA)
- …and pharmacovigilance functions. Develop and implement strategies to ensure compliance with FDA and other global regulatory requirements. Serve as the subject ... This role is responsible for ensuring compliance with applicable regulatory requirements, driving continuous improvement, and providing strategic oversight of… more
- MCKESSON (Fort Worth, TX)
- …while managing operational priorities. Specialized Knowledge & Skills Knowledge of FDA and other regulatory agencies. Knowledge of wholesale distribution ... organizational, and leadership skills. Experience with SOP development and regulatory compliance. Leadership Experience Requirements Minimum of 5-7 years of… more
- Eisai, Inc (Durham, NC)
- …requirements worldwide and stay current with labeling guidelines and regulations by FDA , EMA and other applicable regulatory authorities. Represent the Global ... for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive ... and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory , Program Management, etc.) to shape and refine Clinical Development… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional ... regulatory strategy, objectives, policies, and programs pertaining to developing...Experienced in responding to inquiries from HAs. (EMA & FDA ) Extensive experience with biologics and/or small molecule Formation… more
