- Cipla (Fall River, MA)
- …is a plus. Experience Experience with product development process as applied to 505(b)(1) NDA and/or 505(b)(2) NDA and/or BLA product registration pathways is a ... must. Experience in handling complex injectable and Inhalation. Prior experience in managing projects with internal and/or external stakeholders (eg, CROs, CDMOs) is a must. Handling Green field project is plus. Experience with project governance practices is… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …considerations.Proven track record of contributing to successful IND/CTA and BLA/ NDA filings.Strong understanding of FDA, EMA, and ICH regulations pertaining ... to toxicology and CGT development.Experience working with CROs and managing GLP-compliant study execution.Demonstrated leadership, communication, and organizational skills.Ability to translate complex scientific findings into clear, actionable recommendations… more
- Novo Nordisk Inc. (Boulder, CO)
- …formulation development CROs to implement new production processes at CMOs and NDA -enabling work. Processes may include but are not limited to formulation, ... sterilization, filling, and lyophilization Responsible for key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needs Rapidly and accurately… more
- AUROBINDO (Dayton, OH)
- …Literature Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA ) filing process in line with QbD elements in generic product ... developmentExperience working with projects from bench-top stage to large scale manufacture of submission batchesShould have a sound knowledge of pharmaceutics, pharmacokinetics and process scale-up Qualifications - Skills & Requirements3-5 years of Senior… more
- Amphenol CIT (Snoqualmie, WA)
- …goals without schedule risk. . Qualifies and onboards new suppliers; leads NDA /MSA/SOW/PO terms with Legal/Compliance. . Secures long-lead items and tooling; manages ... capacity and material risk. . Monitors supplier OTD (On-Time Delivery) and quality; leads RCCA (Root Cause Corrective Action) for escapes and implements prevention. . Maintains accurate item masters/BOMs, lead times, and pricing in ERP/PLM; supports ECOs… more
- CSL Behring (King Of Prussia, PA)
- …Reports (CSR). + the clinical sections of relevant regulatory packages (eg IND, NDA , annual reports) and support regulatory RFIs as needed. + the development of ... abstracts, presentations, and manuscripts as appropriate. **Main Responsibilities** 1 Clinical Development Team (CDT) Leadership: + Provides leadership and guidance to all members of the cross-functional CDT acting as the lead scientific expert for the… more
- CSL Behring (King Of Prussia, PA)
- …Reports (CSR).** **the clinical sections of relevant regulatory packages (eg IND, NDA , annual reports) and support regulatory RFIs as needed.** **the development of ... abstracts, presentations, and manuscripts as appropriate.** **Main Responsibilities:** 1 Clinical Development Team (CDT) Leadership: + Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical… more
- Applied Research Associates, Inc. (Nashua, NH)
- …classified account requests, execution of the SF 312 Non-Disclosure Agreement ( NDA ), process and managing personnel clearances + Provide employees with personnel ... security guidance consistent with the 13 adjudicative guidelines to assist them in managing their clearances + Apply physical security concepts to improve security in depth posture + Maintain Intrusion Detection System (IDS) and Access Control Systems in… more
- Arvinas (New Haven, CT)
- …Food and Drug Administration (FDA) accepted the New Drug Application ( NDA ) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor ... degrader- for its use as a monotherapy in the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based… more
- Verdantas (Tampa, FL)
- …other leaders on project execution and delivery + Contribute to MSA, NDA , Terms, contract negotiations, set-up, and Vendor partnership agreements + Request billing ... and payment terms with clients and participate actively in Accounts Receivable efforts + Communicate client activity/satisfaction and identify opportunities that need additional support from leadership within the group + Foster a positive relationship with… more
- WuXi AppTec (Atlanta, GA)
- …on experience. **Responsibilities** **Responsibilities** + Source, close and support IND and NDA services deals with existing and new clients in the Pharma & ... Biotech market. + Identify regional pockets with the highest growth potential and execute accordingly + Execute local marketing and product launch programs in conjunction with the corporate product management and marketing team. **Technical Skills /… more
- Parexel (Helena, MT)
- …in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA , DMF) - In-depth understanding of drug development, manufacturing processes, GMP, and ... regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! Skills & Attributes - Strategic and proactive mindset with strong operational execution - Excellent analytical, problem-solving, and… more
- BeOne Medicines (San Mateo, CA)
- …submissions, eg, IND/CTA (General Investigational Plans, China Risk Control Plans), NDA /MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and ... other Clinical Study Team (CST) members. + Lead the authoring of Storyboards and Briefing Books for HA interactions. + Support ad-hoc review of the Safety Management Plans. + Lead Safety Science specific investigator training. + Risk Assessment, Regulatory… more
- Somatus (Mclean, VA)
- …organization + Previous exposure and solid understanding of the M&A process ( NDA , LOI, DD, SPA, PMI, etc.) + Excellent interpersonal, communication, and team ... leadership skills + Outstanding technical / conceptual understanding of finance and valuations + Excellent knowledge of MS Office tools (Excel, PowerPoint) Other Duties Reasonable accommodations may be made to enable individuals with disabilities to perform… more
- Revelyst (Hyde Park, UT)
- …suppliers globally + Negotiate, implement, and manage supplier contracts, exclusivity, and NDA agreements + Drive lean improvement to help improve profitability and ... drive supply base reduction + Maintain broad knowledge of global market trends for assigned categories + Maintain accurate Sourcing vendor records and master data within all ERP systems + Develop sourcing strategies that align with sustainability goals,… more
- Revelyst (Irvine, CA)
- …and negotiate, implement and manage supplier onboarding, contracts, compliance, exclusivity and NDA agreements + Maintain broad knowledge of global market trends for ... assigned categories and conduct regular benchmarking exercises to evaluate costs and capabilities of incumbent and potential new suppliers globally + Influence continuous process and tool improvement opportunities to help improve efficiencies and profitability… more
- BeOne Medicines (San Mateo, CA)
- …with global, regulatory submissions and interacting with major health authorities; NDA (New Drug Application) and/or BLA (Biologics License Application) submission ... experience strongly desired. + Ability to effectively communicate at multiple levels of the organization. **Education/Experience Required:** + Advanced degree /10+ years in drug development, product strategy & global commercialization, leading cross-functional… more
- ASRC Industrial Services (Oak Ridge, TN)
- NDA Analyst - Engineer - Oak Ridge, TN Summary **Title:** NDA Analyst - Engineer - Oak Ridge, TN **ID:** 2252 - RSI - 02 Description _ASRC Industrial and its ... **Position Summary** RSI is actively seeking a Nondestructive Assay ( NDA ) Professional to support the NDA Program...Nondestructive Assay ( NDA ) Professional to support the NDA Program for the UCOR Cleanup Projects at Heritage… more
- Leidos (Annapolis Junction, MD)
- …**Leidos** has a new and exciting opportunity for a **Senior Linux Systems Administrator** in our **National Security Sector's (NSS) Cyber & Analytics Business Area ... (CABA)** . Our talented team is at the forefront in Security Engineering, Computer Network Operations (CNO), Mission Software, Analytical Methods and Modeling, Signals Intelligence (SIGINT), and Cryptographic Key Management. At **Leidos** , we offer… more
- System One (Florham Park, NJ)
- …Must have Module 5 expertise. + Must have regulatory strategy experience in IND/ NDA development, not just life cycle management. + Must have regulatory strategy ... experience in IND/ NDA development, not just life cycle management. Overview Support...in development (including 2 new IND applications and 1 NDA ) + Knowledge of and Compliance with FDA, EMEA,… more
Related Job Searches:
NDA Analyst Engineer,
Nursing Department Assistant NDA