- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.In this role, you will...of the job include:5+ years of relevant experience in drug product label/labeling required,Experience with labeling equipment qualification and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …and federal environmental regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ... submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory ...to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business System (DBS) tools to drive… more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Butterball (Garner, NC)
- …verification programs. This will include serving as the point person for regulatory agencies conducting the audit, as well as verification of program implementation ... and Abilities. Ample experience in food safety, quality assurance and/or regulatory affairs within the food/meat/poultry processing industry. Some experience related… more
- Butterball (Clinton, NC)
- …practices are completed and documented appropriately. Ensures compliance with all FDA and regulatory requirements, including necessary documentation.4. Partners ... the feed production process* Firm understanding of safety and regulatory compliance standards in manufacturing* Administrative experience within logistics and/or… more
- Boehringer Ingelheim (Ridgefield, CT)
- …associated with Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in ... areas of pharmaceutical law, one of which must be FDA Regulatory (eg, Transactions, FDA ...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory matters, including labeling negotiations, advertising and promotion, drug safety, market research, scientific exchange, market access and patient ... We are looking for a Director Product Counsel for the Regeneron Regulatory and Commercial Law team to provide proactive and collaborative legal advice and counsel in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory relevant ... and/or supplemental applications and post marketing reports per US FDA regulations. Responsible contact for US regulatory ...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- CVS Health (Alexandria, LA)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- AdventHealth (Orlando, FL)
- … (IND), investigational device exemption (IDE), and/or biologics applications to the FDA . The Research Regulatory Specialist III supports AHRI investigators and ... of record for each study protocol, the Food and Drug Administration ( FDA ), and the investigator, the...applications. Provides data and document collection and compilation for regulatory filing with the FDA and other… more
