- Danforth Advisors (Boston, MA)
- …seeking an experienced Managing Director with expertise in selling clinical and regulatory consulting services to life sciences companies. This role will ... of finance and accounting, strategic communications, human resources, risk management, clinical and regulatory , and commercial readiness and launch. Founded… more
- Astrix Technology (GA)
- **Business Development Director , Clinical & Regulatory (Remote)** **POSITION** **Reports To:** VP of Scientific Staffing **FLSA Status:** Exempt **ROLE** ... **SUMMARY** The Business Development Director , Clinical & Regulatory , will...but will lead cross functionally in partnership with regional Managing Directors and Recruiting Managers. **QUALIFICATIONS** + **Education** :… more
- Lilly (Indianapolis, IN)
- …The **Senior Director /Executive Director ** is responsible for managing all Regulatory activities (strategy and implementation) for assigned programs ... advice meetings, and provide regulatory education. + Provide regulatory leadership to program teams supporting first-in-human clinical trials through… more
- Ascendis Pharma (Princeton, NJ)
- …to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will be an internal expert ... governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- BeiGene (San Mateo, CA)
- …with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory ... on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical...and plan holistically in order to develop a NA regulatory position consistent with business needs. Managing … more
- ADM (Kennesaw, GA)
- **92116BR** **Job Title:** Associate Director , Microbiome Regulatory Science - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs, ... the RSA global microbiome strategy. In addition, review and provide feedback on clinical trial protocols and publications. + Track regulatory and scientific… more
- BeiGene (San Mateo, CA)
- …NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory ... The Executive Director , Global Regulatory Portfolio Lead will...leadership on projects including, but not limited to, global regulatory strategies, regulatory requirements for clinical… more
- BeiGene (Emeryville, CA)
- …companion diagnostics or related diagnostic products. + Proven track record of managing regulatory submissions and approvals for diagnostic devices, ideally ... The Executive Director of Regulatory Affairs, Companion Diagnostics...+ Act as the primary point of contact for regulatory bodies, managing relationships and communications to… more
- BeiGene (San Mateo, CA)
- …with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory ... The Executive Director , Solid Tumor North America Lead will be...on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical… more
- Charles River Laboratories (Northridge, CA)
- …at Cell Solutions, you will make a difference every day. **Job Summary** The Director , Regulatory Affairs and Quality Assurance is responsible for ensuring the ... department. * Review SOPs and policies to ensure compliance with applicable regulatory requirements to assure that products have the safety, quality, identity,… more
- Taiho Oncology (Princeton, NJ)
- …through launch leading to post approval commercial support. + Previous experience managing regulatory affairs functional areas and external CROs and consultants ... Associate Director , Regulatory Affairs Strategy Princeton, NJ,...incumbent will be assigned to lead/support one or two clinical development programs as Regulatory Lead (RL),… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... plans to management and other internal stakeholders + Perform regulatory review of all clinical and nonclinical...regulatory landscapes to maintain current knowledge + Effectively managing timelines while working in a fast-paced and dynamic… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the ... with other functional areas such as commercial, regulatory , pharmacovigilance, CMC, and pre- clinical development in this regard. The Director will be a key… more
- Danaher Corporation (Chicago, IL)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... + Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial...required, with a minimum of 3 years in a managing a team. + Experience leading regulatory … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …(ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director , Clinical Development will provide ... such as commercial, regulatory , pharmacovigilance, CMC, early clinical and pre- clinical development in this regard. The Director will be a key… more
- Walgreens (Deerfield, IL)
- …+ Experience in regulatory and compliance + Experience in leading and managing a large team of clinical operations professionals, preferably within an SMO ... and business growth through strategic partnerships, innovative practices, and integration of clinical trial activities. The Director , SMO is responsible for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. + Leads ... your future at Takeda. Join us as a Medical Director - GI & Inflammation- Rheumatology, in our Cambridge, MA...clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions.… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking a Director to join our Clinical Development team. The Director Clinical Sciences leads in the development, evaluation, planning and ... scientific integrity and interpretation of study data of a clinical development program. The Director leads in... drug development experience. Imaging experience and experience in managing cardiovascular and/or metabolic clinical trials is… more
- Brookdale Senior Living (Los Angeles, CA)
- …as one of America's Greatest Workplaces for Diversity Currently Hiring for a District Director of Clinical Services (Regional Director ) to provide strategic ... our residents is the top priority. As a District Director of Clinical Services (Regional Director...receives the highest standard of care while adhering to regulatory compliance and best practices. If you're ready to… more