- Jazz Pharmaceuticals (Palo Alto, CA)
- …Brief Description:As a member of the Pharmacovigilance & Risk Management Team, the Senior Director , Medical Safety Physician will be responsible for monitoring ... subject matter expert to departmental process improvement initiatives.Maintain knowledge of global regulatory authority regulations (especially FDA and EMEA) and… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …applying model-informed drug development in multiple therapeutic areasExtensive understanding of global regulatory requirements and significant experience in ... apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives ... www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Associate Director , Clinical Data Innovation is responsible for overseeing all… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives ... Late Development Team (LDT) in establishing and executing on a global product(s) strategy, which integrates scientific rationale, clinical development, nonclinical… more
- Amgen (Washington, DC)
- …worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology** **Live** **What ... Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is: + To lead GRTs within Amgen's GRAAS organization… more
- BeiGene (San Mateo, CA)
- **General Description** + The Senior Director , Global Regulatory Lead will be responsible for developing, implementing, and advising on global ... and implementation of department policies. **Responsibilities** + Uses extensive knowledge of global regulatory environment and the ability to apply knowledge… more
- Lilly (Indianapolis, IN)
- …for people who are determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC, Small ... to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global ... Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the… more
- BeiGene (San Mateo, CA)
- **Position Summary:** The Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence ... BeiGene's corporate vision, mission, and values. As the Head of Global Regulatory Operations, the SD will lead key functions (Submission Operations Management… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements.… more
- Novo Nordisk (Princeton, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Google (San Francisco, CA)
- …engagement with governments and regulators while mitigating risk. As Senior Director , Regulatory Affairs, Content Advisory Global Lead, you'll join ... + 15 years of experience in legal, compliance, and regulatory risk. + Admitted to the bar and in...and partnering effectively with cross-functional teams. + Experience managing global teams and other managers. + Experience working with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs,... Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC...to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is ... major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for...(Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: May 19, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II...as a liaison in stakeholder management. + Participate in Global Regulatory Operations management team meetings. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 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...analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right… more
- BeiGene (Emeryville, CA)
- **General** **Description** **_:_** **The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising ... on global regulatory strategies for development programs to...senior management.** **Interacts with external business partners and Regulatory Agencies.** **Behavioral Competencies:** **Integrity** **- Ability to demonstrate… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will ... regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross...IVDs (eg, Study Management, Clinical, Biomarkers) and presents to senior leadership as required. + Develops, lead, and communicate… more
- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... management and advice on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both… more
