- 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 ... and clinical development teams, along with external consultants. The Head of Regulatory Affairs will...guiding the strategic direction of development programs to meet regulatory approval standards on both US 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 ... team in PDT, you will report to our Head of Regulatory Affairs , and...+ Excellent verbal and written communication skills. **More about us :** At Takeda, we are transforming patient care through… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... 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 resolution.… 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 ... to the terms and conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer, Gilead Sciences Inc. is committed… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head , Global Regulatory Affairs Marketed Products and Labeling, ... **Working within Labeling Team and GRA** + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US Labeling Operations, EU Labeling… 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 international regulations and policies setting processes of major regulatory agencies (eg US FDA, EU, PMDA,...an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health… more
- Sumitomo Pharma (Columbus, OH)
- …. **Job Overview** The Vice President, Head of Medical and Scientific Affairs ... a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe… 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 ... results. + Perform other duties as assigned by the Head of Quality and Regulatory Affairs...30,000 consultants and more than 4,500 clients across the US , Canada, Asia and Europe, Actalent serves many of… 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...in certain states and cities within the United States . Final determinations with respect to… more
- Chiesi (Cary, NC)
- …Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US **_About us_** Based ... Global Regulatory Affairs Manager Date: Nov 25,..., assist in the identification of the EU and US regulatory requirements applicable to supported regions… more
- BeiGene (Emeryville, CA)
- …medical affairs , legal, healthcare compliance and other business functions in the United States and Canada to ensure compliance with applicable regulatory ... **General Description:** Reporting to the Head of Regulatory , Advertising/Promotion, this role...cross-functional teams for product labeling, product development teams, medical affairs , and marketing. + May provide advice on healthcare… more
- AbbVie (South San Francisco, CA)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles ( US and Canada) can be based in ... requirements. 6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development &… 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
- 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 ... this is just the beginning of our journey. Join us as we pursue our purpose to make the...better for everyone. ServiceNow is looking for a government affairs professional to join a global team for a… more
- Chiesi (Cary, NC)
- …initiatives. Additionally, this role involves a key partnership and co-creation with the ex- US (ROW) Medical Affairs Head for Seralutinib to shape ... partnership with the alliance partner and the ROW Medical Affairs Head . + Incorporates insights from the... Affairs Respiratory Team, providing medical input on US labeling and regulatory interactions. + Collaborates… more
- Gilead Sciences, Inc. (Foster City, CA)
- …, US Commercial, US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and compliance + Represent US ... regulatory and legal (Business Conduct) requirements for US Medical Affairs activities. + Able to...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Citigroup (Tallahassee, FL)
- …as assigned. The position will report to the Head of State and Local Government Affairs , and be a member of the US Government Affairs team headquartered ... (SLGA) team oversees lobbying activity in the 50 States and key cities in the US .... **Time Type:** Full time **Primary Location:** Telecommuter Florida United States **Primary Location Full Time Salary… 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 ... in which the hired candidate will be working in the US , the salary ranges provided are shown in accordance with US law and apply to US -based positions. For… more
- Corteva Agriscience (IN)
- **Position: Head , Government Affairs - South Asia** **Location: Flexible. Preferred : Gurgaon/ New Delhi** **Position Summary** The Head , Government ... positions on legislation and regulatory proposals, levering Business Unit, Regulatory , Legal and Government & Industry Affairs network resources. She/he… more