- 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 ... to learn, grow and become your best self. Become a **maker of possible** with us. The Sr . Director , Regulatory Affairs is the ranking Regulatory … 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Bio-Techne (Minneapolis, MN)
- …R&D Systems will lead a team of Regulatory professionals, working closely with the Sr . Director , Regulatory Affairs and the R&D Systems (RDS) Quality ... identified by Business Partners Internal Stakeholders + Lead the high-functioning, service-oriented Regulatory Affairs team at the R&D Systems site in… 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
- 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
- American Heart Association (Washington, DC)
- …**Washington, DC** office (hybrid work arrangements available. Under the direction of the Director , Federal Regulatory Affairs , you would be responsible for ... career. The **American Heart Association** has a phenomenal opportunity for an **Associate** ** Regulatory Affairs Manager** with our Federal Advocacy Team in our… 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
- Florida Crystals Corporation (Boca Raton, FL)
- …POSITION SUMMARY The R egulatory Affairs Specialist reports directly to the Director of Global Regulatory Affairs . This position is responsible for ... regulatory critical path activities + Support the Director of Global Regulatory Affairs ...those outside the formal line of authority (eg, peers, senior managers - not subordinate) EDUCATION REQUIREMENTS + Bachelor's… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... applicable, ensure direct reports follow requirements. + Ensures alignment of global regulatory strategies with Sr . Management. Under minimal guidance of… more
- NJEDA (NJ)
- Overview Job Summary Under the supervision of the Director of Legislative & Regulatory Affairs , the Senior Advisor supports all aspects of the duties of ... the Legislative & Regulatory Affairs Department, including but not limited to drafting and tracking legislation that directly and indirectly impacts NJEDA and… more
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