- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs , Patient Safety and Pharmacovigilance to implement ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Exponent Inc. (Washington, DC)
- …responsible for Providing technical expertise to our clients related to food science, regulatory affairs , product approvals (GRAS, FAP, AAFCO, novel foods ... is to engage multidisciplinary teams of science, engineering, and regulatory experts to empower clients with solutions that create...Offices globally Our Opportunity We are currently seeking a Senior Food Scientist for a Senior… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- …will be essential *Interact with scientists, medical directors, and Technical Operations / Regulatory Affairs personnel for the timely completion of clinical ... Title: Sr . Director, Clinical Pharmacology Reports to: SVP, Clinical...our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and… more
- Bio-Rad Laboratories, Inc. (Hercules, CA)
- As a Senior Staff Scientist . you`ll be right at the forefront of Bio-Rad's Clinical Diagnostics R&D Group - leading the design and validation of clinical ... coordination and execution of design validation studies in collaboration with clinical affairs , human factors, R&D, marketing and sales specialists to gather user… more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA CMC-Parenteral Commercial Products to be a part of the Lilly ... tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and … more
- Merck (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as needed + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate innovative regulatory… more
- Lilly (Indianapolis, IN)
- …BU Medical, other MDU Functions, Clinical Development (early and late phase), Regulatory Affairs - North America and International, regional/affiliate brand ... for people around the world. The purpose of the Sr . Director - Safety Data Scientist role...enable compliance, in an environment of continuous and disparate regulatory changes worldwide including: + Responsible for the development… more
- Herbalife (Winston Salem, NC)
- Sr . Scientist , R&D Category: Research &...process) * Propose DOEs as appropriate, acquire support from senior technical scientist * Support cost saving ... share to linkedin Apply Now **Overview** THE ROLE: The Sr . Scientist serves as a technical contributor...teams such as Marketing, Sourcing, Quality, Licensing and Scientific Affairs in project teams * Identify new food ingredients… more
- Abbott (Santa Clara, CA)
- …+ Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory ... + Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality… more
- Herbalife (Torrance, CA)
- …routinely with Herbalife global cross functional teams including Quality, Procurement, Regulatory Affairs , Project Management and Supply Chain as well ... Sr . Research Scientist , Process and Mfg...launches, smooth commercial production, and compliance with quality and regulatory standards as well as on target profit margin.… more
- Danaher Corporation (Fargo, ND)
- …safeguard and improve human health. This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be on-site. ... the Analytical Method Validation Team and report to the Sr . Manager of Analytical Method Validation and will be...manner. Aldevron is seeking a highly skilled and experienced Senior Scientist to join our Analytical Method… more
- Cambrex High Point (High Point, NC)
- …world. Start a career where You Matter by applying today! Job Overview The Senior Scientist , Regulatory Compliance will provide oversight of regulatory ... GXP/QA/ regulatory compliant pharmaceutical laboratory environment or Quality Assurance/ Regulatory Affairs role (prefer late phase/commercial experience).… more
- Lilly (Indianapolis, IN)
- …life-changing new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small ... the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative … more
