- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director / Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... to the continuous improvement of processes and standards within Regulatory Affairs . If you have a strong...Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director … more
- 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
- Ascendis Pharma (Princeton, NJ)
- …As part of the Regulatory Affairs team, you will report to the Senior Director Regulatory Affairs , Advertising and Promotion. There is a ... as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and...help evaluate and mitigate potential risk. + Present to senior management and cross-functional teams regarding shared learnings from… 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...+ Other relevant US laws, regulations and guidance documents Director Qualifications: + Bachelors Degree in life sciences, pharmacy,… 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
- Medtronic (Miami, FL)
- …Life** As a member of the Mechanical Circulatory Support (MCS) Leadership Team, the Senior Director of Regulatory Affairs leads a team of regulatory ... regulatory activities. + Leads a strong, diverse regulatory affairs team with the competencies required...+ Business Acumen- Significant experience as a member of senior business leadership teams.- Demonstrated ability to partner to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you will oversee the development and execution… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety, and Development… more
- HCA Healthcare (Louisville, KY)
- …Summary and Qualifications** The Senior Director of Accreditation, Compliance, and Regulatory Affairs will lead the College in the areas of regional and ... the lives of many. Jump-start your career as a Senior Director of Accreditation - Compliance -...programmatic accreditation, compliance, regulatory affairs , risk management, and state licensing… more
- Mount Sinai Health System (New York, NY)
- …CMO - MSH, Mount Sinai Hospital **Responsibilities** In collaboration with Senior Director of Regulatory Affairs , and other system leadership, directs ... **Job Description** A member of MSHS regulatory team, the Accreditation Specialist is a key...leader and participant in the systems continuous accreditation and regulatory readiness program. Responsible for providing direction and oversight… 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
- Takeda Pharmaceuticals (Columbus, OH)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external CRO… 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
- Arvinas (New Haven, CT)
- …of the medical affairs plans for Arvinas' neurology pipeline assets. The Senior Medical Director will provide strategic input to and collaborate with ... Summary** Arvinas has an exciting opportunity for an experienced Senior Medical Director to join our team...Director will be a member of the Medical Affairs Leadership Team and is responsible for executing strategy… more
- Lilly (Indianapolis, IN)
- …how Lilly and LRL operates. The ** Senior Director /Executive Director ** is responsible for managing all Regulatory activities (strategy and ... with focus on US, UK, EU, and Canada. The Senior Director /Executive Director works with...college or university + At least 7 years of regulatory affairs experience with research-based drug development,… 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