- Arcellx (Redwood City, CA)
- …respect a diverse set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs, you'll lead and drive ... Arcellx's clinical regulatory approval strategy and implementation and oversee post-approval ...Candidates with less experience may be considered at the director level. Proficiency directly writing submission documents that support… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction, acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CM&C and other ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... 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
- Dennis Partners (Boston, MA)
- …for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on global ... with senior Regulatory leaders.Author/edit documents to support regulatory submissions.Compile, review, approve and submit clinical trial and marketing… more
- AstraZeneca (Boston, MA)
- …regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior Director level). You will work across ... and considered an equal partner in the business. The Senior Regulatory Affairs Director (SRAD),...and procedural/operational issues as they arise. Actively collaborating with Senior Management and Enterprise functions (eg, Clinical ,… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all ... assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Abdera Therapeutics (San Francisco, CA)
- …meetings to provide regulatory support and guidance and manage day-to-day regulatory activities.Provide guidance and expertise to senior management and other ... experience with FDA submissions required.Skills & AbilitiesAbility to critically review regulatory scientific documents across non- clinical and clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position ... ability to function as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical ...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational work ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will aid in the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents. Responsibilities:Develop ... plans, clinical protocols, and in the submission of certain regulatory documents from the translational perspective. Provide translational deliverables (eg data,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Avidity Biosciences (San Diego, CA)
- …of experience in pharmaceutical/biotech with a minimum of 4+ years in clinical Regulatory AffairsComprehensive knowledge of current US and ex-US regulations ... Job Title: Associate Director - Regulatory AffairsLocation: San Diego,... Authority meetingsAssist in the management and oversight of regulatory activities relating to clinical trials and… more
