- Lundbeck (Fort Wayne, IN)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor… more
- Merck & Co. (Rahway, NJ)
- …PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( ... FDA , EMA, PMDA),Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise,Up-versioning activities to specific versions of… more
- Merck & Co. (Rahway, NJ)
- …knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.-Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate ... engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …(Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for ... Team to help our company build solid and trustworthy relationships with FDA and global health authorities.- Pro-actively influences and manages relations with … more
- AUROBINDO (Durham, NC)
- …documents to broker to expedite receipt of incoming product through customs and the FDA . The position is also required to work closely with Quality Control to make ... of each formulation for each line.Communicating with brokers for timely FDA release of materials.Measuring and reporting effectiveness of the department… more
- Twist BioScience (South San Francisco, CA)
- …Ensure our custom MES solutions comply with GxP regulations (eg, cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee ... (eg, SQL Server, Oracle, PostgreSQL).Extensive knowledge of GxP regulations (especially cGMP), FDA 21 CFR Part 11, and Eudralex Annex 11, with practical experience… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, ... effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, ... effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and… more
- Aequor (Hicksville, OH)
- …cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, ... effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and… more
- Aequor (Athens, GA)
- …environment. Preferably experience with Documentum, MS Teams, MS Sharepoint. 21CFR Part 11, GLP ( FDA and EPA), GMP ( FDA and EU), VICH Internal BI policies on ... Records Management, Training Management, Information Protection. The individual must be very detail oriented and able to follow precise instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly… more
- Tris Pharma (Monmouth Junction, NJ)
- …(SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration ( FDA ) standards. She/he also provides and monitors the continuous flow of ... is cleaned to meet production schedule and in accordance to strict SOP, FDA and cGMP standardsSupports and assists with daily cleaning functions, as needed (vaults,… more
- Merck & Co. (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... regulatory filings (IND, MAA, BLA) and inspections with multiple agencies ( FDA , EMA, JNDA, TGA).-Current Employees apply HERE Current Contingent Workers apply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position ... documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager.Regulatory Knowledge:… more
- Eisai, Inc (Nutley, NJ)
- …for US. Responsible for oversight and strategic planning of the meetings with FDA , EMA, PMDA. Provide strategic support for meetings with other Health Authorities ... the CDE. Actively participates in Health Authority GCP inspections (eg, FDA , EMA, PMDA) including responding to observations and development of corrective actions.… more
- Tris Pharma (Monmouth Junction, NJ)
- …Ensures compliance with all current GxPs, Food and Drug Administration ( FDA ), Drug Enforcement Administration (DEA), and Occupational Health and Safety ... sourcing, contract negotiation, and supplier management Strong knowledge of FDA regulations, current Good Manufacturing Practices (cGMPs) and pharmaceutical supply… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to determine ... change control activities for systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification of new and existing… more
- Eisai, Inc (San Jose, CA)
- …clinical information to customers and key stakeholders consistent with the FDA -approved indication. Additionally, the Senior NAS will be responsible for ensuring ... customers are educated on the simplest patient journey to therapy within their assigned geography. The individual must be able to utilize exemplary interpersonal skills to uncover and address the customer's educational needs. The Senior NAS will be required to… more
- Lundbeck (Waco, TX)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must… more
- Merck & Co. (Durham, NC)
- …with responding to regulatory questions with multiple agencies ( FDA , EMA, JNDA,).Experience authoring technical documents supporting regulatory filings ... (IND,BLA)Experience with assay development, validation, or technical transfersEquipment ValidationKnowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industryExperience in regulatory agency audits and/or regulatory… more
