- 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
- 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 , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC...major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for… more
- Medtronic (Boston, MA)
- …guidance you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory ... technologies to market. It involves creating, managing and executing global regulatory strategies for new product development... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Apr 20, 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
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead will provide strategic ... Regulatory Affairs (GRA) on the Evidence Team. The Director , Global Regulatory Strategy Lead...team members, encourage cross-functional coordination and coordinate with the ( senior ) regulatory project manager to achieve … more
- Scotiabank (New York, NY)
- Director , Internal Control - Global GBM Regulatory Controls **Requisition ID:** 197516 **Salary Range:** 174,700.00 - 286,000.00 _Please note that the Salary ... heavily with stakeholders, including Compliance, Operations, Internal Control, Client Onboarding, Global Regulatory and Compliance Technology and the Business,… 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …Summary:** The Director , Development & Operations Lead (DevOps Lead) - Global Regulatory Sciences is accountable for leading the technical engineering, ... operations, and technical architecture teams in support of all Global Regulatory Sciences IT (GRS IT) Product...Regulatory Sciences (GRS) organization and impacted adjacencies. The Director will work closely with leaders across the GRS… 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
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Senior Director , HTA, Value & Evidence (HV&E) mRNA will support the strategic goals of the mRNA Vaccines Team by driving optimal patient ... by demonstrating the value of our vaccines. The HV&E Senior Director will be accountable and responsible...enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers. +… more