- Actalent (Bridgewater, NJ)
- Job Title: Head of Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the ... Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of management and… more
- Takeda Pharmaceuticals (Boston, MA)
- …you will provide high-level comprehensive administrative support for the Plasma-derived Therapies Business Unit Head of Regulatory Affairs and Head of ... of the Regulatory team in PDT, you will report to our Head of Regulatory Affairs , and manage special projects, events and operational matters as assigned… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US ... . Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach… more
- Amazon (Arlington, VA)
- …remove blockers, and will deliver results across the world. You will report to the Head , Licensing & International Regulatory Affairs for Project Kuiper and ... difference in bridging the digital divide. The Senior lead, Licensing and Regulatory Affairs works to align the licensing strategy with business and service… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidelines and regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at ... headquarters in Foster City, California._ **Senior Director - Analytical Regulatory ** **Science** **KEY** **RESPONSIBILITIES** The Sr Director, Analytical … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head , Global Regulatory Affairs Marketed Products and Labeling, ... and assures that Takeda labeling content and processes conform to regulatory requirements. **Management of Local Exceptions and LOC Interactions** + Manages… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing… more
- Sumitomo Pharma (Columbus, OH)
- …. **Job Overview** The Vice President, Head of Medical and Scientific Affairs ... key stakeholders. The Vice President will lead the global medical affairs functions for investigational and marketed products. **Job Duties and Responsibilities**… more
- Sanofi Group (Cambridge, MA)
- …or protected veteran status, or any other characteristics protected by applicable law. The Head of Rare Diagnostics is a key member of the Rare Global Medical ... Affairs leadership team in the Rare Disease franchise. The...statement of work, joint steering meetings, design control oversight, regulatory assessment and launch readiness. + Serve as the… more
- Actalent (Azusa, CA)
- …to ensure timely response for results. Perform other duties as assigned by the Head of Quality and Regulatory Affairs . Retrieve information from the ... response for results. + Perform other duties as assigned by the Head of Quality and Regulatory Affairs . + Retrieve information from the computer system as… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the Manager ... of Regulatory Affairs to create and collate product master files (dossiers),...Cosmetic listings, etc.), under the direct supervision of the Head of Quality/ Regulatory . + Assist the Manager… more
- Merck (Philadelphia, PA)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...life cycle of the drug. + Provides leadership as head of the Global Regulatory Team, which… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Manager Date: Nov 25, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & ... Regulatory Affairs Contract Type: Permanent Location: Cary,...Head , assist in the preparation and presentation of regulatory information at internal project meetings; Contribute to global… more
- BeiGene (Emeryville, CA)
- **General Description:** Reporting to the Head of Regulatory , Advertising/Promotion, this role provides regulatory oversight, and strategic guidance on ... marketed products in North America. This role supports our commercial, medical affairs , legal, healthcare compliance and other business functions in the United… more
- ServiceNow, Inc. (District Of Columbia, DC)
- …Global Government Affairs and Public Policy. Reporting to the Vice President, Head of Global Government Affairs and Public Policy, this individual will ... better for everyone. ServiceNow is looking for a government affairs professional to join a global team for a...and inform ServiceNow's leadership on all key policy, legislative, regulatory , and global issues that might impact the Company.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a ... Responsibilities:** + Be a strategic thought partner to the Head of Regulatory about complex problems, current...sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations… more
- AbbVie (North Chicago, IL)
- …will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) are: 1. Responsible for ... requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development &… more
- Chiesi (Cary, NC)
- …this role involves a key partnership and co-creation with the ex-US (ROW) Medical Affairs Head for Seralutinib to shape and align the global medical ... ensuring the strategy effectively addresses the distinct needs and regulatory landscapes of both the US and ROW markets....partnership with the alliance partner and the ROW Medical Affairs Head . + Incorporates insights from the… more
- Corteva Agriscience (IN)
- **Position: Head , Government Affairs - South Asia** **Location: Flexible. Preferred : Gurgaon/ New Delhi** **Position Summary** The Head , Government ... legislation and regulatory proposals, levering Business Unit, Regulatory , Legal and Government & Industry Affairs ...Unit, Regulatory , Legal and Government & Industry Affairs network resources. She/he then ensures teams have the… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Editor will support the Head of Medical Writing Editing and more senior Medical Writing Editors by performing a full QC check of clinical regulatory ... documents, to ensure that they meet company standards and Health Authority guidelines. **A Typical Day in the Role Might Look Like:** + Work independently to perform high-quality QC checks of MW documents (eg, Submission Modules, CSRs, IBs) + Edit ICFs and… more