- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Merck (Boston, MA)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine + Develops worldwide product… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ...around the world. This position is currently classified as " remote " in accordance with Takeda's Hybrid and Remote… more
- Randstad US (Cambridge, MA)
- associate director us regulatory , biosimilars. + cambridge , massachusetts ( remote ) + posted 1 day ago **job details** summary + $150 - $165.37 per hour + ... hours: 9 to 5 education: Bachelors responsibilities: The US Regulatory Associate Director will be responsible for...project teams and subcommittees in all areas of US regulatory affairs and product development. + Set… more
- Merck (Cambridge, MA)
- … regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges ... **Job Description** **Role Summary** + The Associate Director, Medical Operations, Innovation and Emerging Projects...and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, Medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Children's Hospital Boston (Boston, MA)
- 75978BRJob Posting Title: Associate General CounselDepartment:General CounselAutoReqId:75978BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:Legal, ... role will serve as the primary point of contact for legal affairs at Franciscan Children's and other affiliated organizations, providing strategic legal guidance… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May… more