- Merck & Co. (Rahway, NJ)
- … CMC . This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality projects ... as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays a critical role in driving alignment and execution globally across… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory ... to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs , CMC Small Molecules where you will oversee the development and… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Merck (Rahway, NJ)
- … CMC . This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality projects ... as an extension of the overall Regulatory Affairs CMC Leadership Team. This Lead plays a critical role in driving alignment and execution globally across… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + [Preferred]:… more
- ThermoFisher Scientific (Grand Island, NY)
- …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr . Manager, Regulatory Affairs - Drug Support Strategy is… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... manner, independently or under the direction of a more senior scientific leader. This position will be an integral...+ Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... The Analytical Operations department is seeking a highly motivated Senior Scientist to lead our impurities development team. The...program. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support...products and problems. + Works in collaboration with more senior scientists or scientific directors to advance the development… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Pharmacology, Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs , Patient Safety and ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Bausch + Lomb (Juneau, AK)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional,… more
- Sumitomo Pharma (Tallahassee, FL)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
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