- J&J Family of Companies (Raritan, NJ)
- Senior Director , Global Regulatory Leader, CAR-T Therapy - 2406186120W **Description** Johnson & Johnson is currently seeking a Senior Director , ... supports their efforts to have a positive impact on their communities. The Senior Director , Global Regulatory Leader, CAR-T Therapy will be responsible… 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
- 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)
- …oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies ... Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global … 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
- Lilly (Indianapolis, IN)
- …tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ... knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing… more
- AbbVie (Lake Bluff, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... terminology, guidelines, standards, etc. + Experience developing and implementing successful global regulatory labeling strategies. + Experience with InDesign a… 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 (San Mateo, 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
- 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
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Pfizer (New York, NY)
- …the GI scientific narrative and the strategic GI medical plan across assets + The Global Senior Director , GI and Biosimilars will work collaboratively ... SUMMARY** + Reporting to the VP, Global Gastroenterology Medical Lead, the Senior Director , Gastroenterology (GI) and Biosimilars is an integral member of… more
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... regulatory compliance communications to ensure compliance of the Global Quality System with applicable regulatory requirements...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Sanofi Group (Cambridge, MA)
- …advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs (RA) serves...and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global… more