- BeiGene (Emeryville, CA)
- …GxP compliance activities (internal/corporate, CMO or supplier, CRO) and identify regulatory compliance gaps or risks. + Assess, manage training curricula in ... Affairs SOP Committee regarding life-cycle management of Global Regulatory Affairs SOP compliance . To include but...not limited to): + Information Governance (IG) Team + Clinical Operations Emergency Response Team + Global Standards Committee… more
- HCA Healthcare (Nashville, TN)
- …like you to be a part of our team. **Job Summary and Qualifications** The Director of Regulatory and Accreditation- Clinical Education is recognized as an ... Do you want to join an organization that invests in you as a Director Regulatory Education Surgical Services? At HealthTrust, you come first. HCA Healthcare… more
- HCA Healthcare (Nashville, TN)
- …accreditation, certification and licensure compliance of all facilities. HCA Healthcare clinical strategies and regulatory compliance are foundational to ... join an organization that invests in you as a(an) Director Regulatory and Accreditation? At Work from...in an advisory capacity for facility directors for all regulatory compliance as it pertains to facility… more
- Sumitomo Pharma (Columbus, OH)
- …and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level Promotional Activities + ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs** . The Associate Director is part… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to ensure e-CTD compliance . + As required, serves as a global regulatory lead on a specific or assigned clinical program. **Qualifications** + Bachelor's ... on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory… more
- Lilly (Indianapolis, IN)
- …to evolve how Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory activities (strategy and ... advice meetings, and provide regulatory education. + Provide regulatory leadership to program teams supporting first-in-human clinical trials through… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide strategic review… more
- Stryker (San Jose, CA)
- …publicly disseminated information on product submission approval status + Review regulatory compliance requirements for changes affecting product submission and ... link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory Affairs** is a key strategist,… more
- Kelly Services (Ballwin, MO)
- Kelly Scientific is leading the search for a ** Regulatory Affairs Director ** - a permanent role with a pharmaceutical company focused on discovery and ... of new API and pharmaceutical product development. **Title** : Regulatory Affairs Director **Location** : Ballwin, MO...including INDs, NDAs, BLAs, ANDAs, MAAs, and other global regulatory filings. + ** Compliance :** Ensure compliance… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures + Establishes organization ... **Job Description Summary** The Sr. Director , Regulatory Affairs is the ranking...business needs, drive timelines for submission/clearance targets, including EUMDR compliance , and effectively manage the RA team to ensure… more
- ADM (Kennesaw, GA)
- … Science - Kennesaw, GA **Department/Function:** Legal, Compliance , Regulatory Affairs, Corporate Security **Job Description:** **Associate Director ... the RSA global microbiome strategy. In addition, review and provide feedback on clinical trial protocols and publications. + Track regulatory and scientific… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will be an internal expert ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for… more
- Charles River Laboratories (Northridge, CA)
- …at Cell Solutions, you will make a difference every day. **Job Summary** The Director , Regulatory Affairs and Quality Assurance is responsible for ensuring the ... reports to grow the QA/RA department. * Review SOPs and policies to ensure compliance with applicable regulatory requirements to assure that products have the… more
- BeiGene (Emeryville, CA)
- The Executive Director of Regulatory Affairs, Companion Diagnostics (CDx) will be responsible for developing, advising on and executing global regulatory ... strategies for companion diagnostic products supporting development and approved products, ensuring compliance with regulatory agencies such as the FDA, EMA, and… more
- Medtronic (Miami, FL)
- …Life** As a member of the Mechanical Circulatory Support (MCS) Leadership Team, the Senior Director of Regulatory Affairs leads a team of regulatory affairs ... professionals and requires a combination of deep regulatory experience, compliance expertise, technical aptitude, and business acumen. It will be critical that… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The ... Sr Director , Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing and… more
- Guthrie (Corning, NY)
- …for the Primary Stroke Center for the Robert Packer Hospital to assure compliance with accrediting body for stroke program. Experience Must have a PA registered ... nurse license with five years clinical experience. Individual must have proficiency with internet, e-mail,...reviews and updates policies and procedures, collaborates with RPH regulatory department for the advancement of the stroke program,… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance . Ability to draw from ... - as required. + As a GRA CMC member, ensures and / or enhances regulatory compliance . + Ensures project team colleagues, line management, and key stakeholders… more
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