- Astellas Pharma (Northbrook, IL)
- …ensure regulatory compliance and timely submissions. + Partner with drug regulatory affairs, clinical trials unit, clinical development, precision medicine ... and stratification in clinical studies across all phases of drug development. As a Diagnostic Regulatory Strategy Lead, you will be the primary regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …small molecule) + Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification Technical expertise: + In-depth ... expertise in at least one TA and a broad range of global regulatory and drug development topics. + Seamlessly interact and collaborate cross functionally at all… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …guidance for changes to an approved (A)NDA + Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional...or more program(s), including participation in external Food and Drug Administration (FDA) meetings, internal core team meetings and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback ... of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Takeda Pharmaceuticals (Boston, MA)
- …value chain, particularly data taxonomies and domain integration. + Understanding of global drug development & regulatory processes. + Experience with Veeva RIM ... my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information,… more
- Teva Pharmaceuticals (Weston, FL)
- …extended-release, delayed-release, complex generics (including peptides), and combination drug products. + Regulatory submissions: P-INDs, INDs, ... Regulatory Affairs Associate III Date: Oct 30, 2025...following: . Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …as an inpatient hospital pharmacist.** Experience in medication safety, compliance, drug diversion and/or regulatory . **Be inspired. Be rewarded. Belong. ... Job Summary: We are seeking an experienced pharmacist to oversee our regulatory and compliance program as it relates to federal and state requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, ... the USA or more jurisdictions. + Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market… more
- Sanofi Group (Morristown, NJ)
- …and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** :...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Sanofi Group (Cambridge, MA)
- …regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products. The ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ Cambridge, MA **About...**Main Responsibilities:** + Enables the GRL by providing quality regulatory input and position to internal business partners, including… more
Recent Jobs
-
Equity Research Associate - Power & Utilities
- Truist (New York, NY)
-
Sr Lifecycle Operations Engineer
- GE HealthCare (Waukesha, WI)
Related Job Searches:
Drug,
Drug Regulatory Associate,
Drug Regulatory Document Management,
Drug Regulatory Policy,
Regulatory