- Cardinal Health (Helena, MT)
- …Biotech and Medical Device/Medical Diagnostics with success + Experience selling consulting, drug development, regulatory services preferred + Highly organized + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… 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
- Lilly (Indianapolis, IN)
- …and/or visas for this role. **Additional Skills/Preferences:** + Experience counseling on drug regulatory matters in Canada, Brazil and Mexico + Prior ... **Organization Overview:** This position will be part of the Regulatory Legal Team (RLT), which reports up through Lilly's...drug , medical device and diagnostic clinical programs and regulatory submissions in the US and other Americas Region… 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
- Taiho Oncology (Princeton, NJ)
- …except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and ... requirements. The incumbent may participate in interactions and negotiations with regulatory authorities during the drug development and approval processes… 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
- University of Colorado (Aurora, CO)
- …**Condition of Employment:** **Preferred Qualifications:** + Experience with investigational drug services, clinical research operations, or IRB/ regulatory ... of pharmacy practice** with a particular interest in clinical research, investigational drug management, and regulatory compliance in academic or healthcare… more
- Bristol Myers Squibb (San Diego, CA)
- …while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic ... paired with deep expertise in developing and executing global regulatory strategies across drug and device development. + Regulatory Standards Mastery,… more
- Takeda Pharmaceuticals (Boston, MA)
- … submissions including for Late-Stage assets. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, ... oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody- drug conjugates (ADCs), complex biologics and small molecules. Our… more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Experience in reviewing, authoring, or managing components of regulatory submissions. + Expert knowledge of drug development process and ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Takeda Pharmaceuticals (Boston, MA)
- …inclusive of regulatory and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …of regulatory and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ... on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of...Oncology where you will be part of the global regulatory team. As Associate Director, Global Regulatory … more
- MAAC (Metropolitan Area Advisory Committee) (San Diego, CA)
- …hours and/or units (CEH or CEU) as determined by the Department of Alcohol and Drug Programs and/or other regulatory agencies. + Performs other related duties as ... sessions and workshops for residents on a variety of subjects, including drug and alcohol education, domestic violence, psychological and physiological effects of… more
- Ascendis Pharma (Princeton, NJ)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Regulatory Affairs, Advertising and ... PhD, MS, MBA, JD) preferred. + 7-10+ years' experience in drug , biologic and/or combination products in Regulatory Affairs or related field. + Minimum of 5 years… more
- Lilly (Indianapolis, IN)
- …scientific degree (ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR + Bachelor's degree ... with 10+ years of industry-related experience in regulatory affairs and/or drug development experience **Other Information/Additional Preferences:** + Proven… more
- Teva Pharmaceuticals (West Chester, PA)
- …role that will be responsible for developing, coordinating, and implementing regulatory strategies for drug development programs for innovative biologic ... Director, Regulatory Affairs Date: Jan 8, 2026 Location: West... knowledge of and submission experience with investigational new drug applications (INDs) and new drug applications… more
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. **How you… more
- Ascendis Pharma (Palo Alto, CA)
- …and/or PMP desired. + A minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory Affairs and 3 years of experience ... Management activities within the pharmaceutical and/or biotechnology industries. Orphan drug experience preferred. + Familiarity with Regulatory framework… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Chiesi (Cary, NC)
- …with an expected graduation of fall 2026 or later. + Strong interest in regulatory affairs and drug development, particularly within rare diseases. + Basic ... for you to have + Coursework or prior exposure to regulatory affairs, FDA regulations, or drug development. + Familiarity with FDA regulatory pathways (eg,… more