- 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
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… 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) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes.** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions… more