- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr. Director , Regulatory Affairs is the ranking Regulatory Affairs leader for the Infusion Process Excellence RA ... provides expertise and leadership to business partners, the Assoc Director of Process Excellence Regulatory Affairs , and execute regulatory strategies… more
- Tecomet (Woburn, MA)
- …Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** Senior Director QARA **or EVP of QARA** **Date:** 14 July 2022 **JOB ... provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities… more
- Danaher Corporation (Chicago, IL)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... that safeguard and improve human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... in the pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US ... strategic regulatory guidance to facilitate efficient and compliant drug development...Administration + Provide analysis, advice and guidance on US regulatory strategies. + Provide expertise on regulatory … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the ... Senior Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) role is ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein forumsthatshareregulatoryinformationacrossGRA… more
- AbbVie (Irvine, CA)
- …advance quality assurance excellence mindset. The role reports to the Senior Director of Safety, Vigilance and Medical Affairs Quality Assurance. There is an ... objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical Affairs Quality Standards is responsible… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- Chemours (Wilmington, DE)
- …improvement at a time. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing **Government Affairs ** team! This position ... Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States...public policy agenda and positions. + Interface with Chemours' senior management and business leaders on US federal and… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; Titusville, ... and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional...senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …lead the strategic and operational management of new product introduction, regulatory affairs , permitting, product certification, and market development, ... or a related field. + 15+ years of experience in new product introduction, regulatory affairs , or market development for decentralized sanitation or onsite water… more
- Stanford Health Care (Palo Alto, CA)
- …Brief Overview** The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic planning, oversight and direction of ... accreditation, regulatory , and licensing across Stanford Health Care. This includes... for Quality, Patient Safety & Infection Prevention, the Senior Director collaborates with cross-functional leaders and… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- BeiGene (San Mateo, CA)
- …met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor ... The Executive Director , Solid Tumor North America Lead will be...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... Gilead is a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this… more
- PLUS Communications (Arlington, VA)
- …and media buying. PLUS means more! PLUS Communications is looking for a Public Affairs (Healthcare), Senior Director to provide project management support, ... through the cracks. + Have experience synthesizing complex policy issues and/or regulatory affairs at the federal or state level. + Have a solutions-oriented… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and lead the execution of … more