- Bristol Myers Squibb (San Diego, CA)
- …along with expertise in one or more of the relevant areas (eg, clinical , regulatory , project planning and management, medical, commercial development) + Prior ... plan (IDP) in partnership with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug… more
- Stryker (San Jose, CA)
- …groups or sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents. + Addresses notified body feedback on ... In this role, you will collaborate closely with cross-functional teams, including Regulatory , Clinical , Quality, and Marketing to ensure the successful… more
- AbbVie (Irvine, CA)
- …development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, or GMA) to create development ... professional development and promote the reputation of the Statistics department. + ( Clinical Statistics) Ensure that all applicable regulatory requirements for… more
- AbbVie (South San Francisco, CA)
- …development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, and GMA, etc.) to create ... Associate Director, Statistics - Oncology provides statistical leadership for clinical development and life-cycle management strategies for assigned projects.… more
- Stanford University (Stanford, CA)
- …strong team of regulatory experts responsible for the administration and regulatory compliance of clinical research within the university, and represent the ... skills, teamwork, and superb attention to detail. We strive for top-quality regulatory support of investigator-initiated clinical trials with a high degree… more
- Abbott (Santa Clara, CA)
- …based upon regulatory changes + Support pre and post approval clinical strategy and submission activities + Anticipate regulatory obstacles and emerging ... with US and global product post marketing approval requirements + Evaluate proposed clinical and manufacturing changes for regulatory filing strategies + Execute… more
- Gilead Sciences, Inc. (Foster City, CA)
- …submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development. + Responsible for development of ... respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory… more
- Abbott (Santa Clara, CA)
- …other members of regulatory and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases ... and recommend solutions. + Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. **Required Qualifications** +… more
- Abbott (Santa Clara, CA)
- … regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our… more
- BeOne Medicines (San Mateo, CA)
- … direction and leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing ... regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional… more
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