- Gilead Sciences, Inc. (Santa Monica, CA)
- …we can continue making a positive impact in the cancer field. The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing ... Diploma/GED and 14+ years of relevant industry experience Preferred Qualifications: + Regulatory review of promotional materials for prescription drug and/or… more
- Abbott (Santa Clara, CA)
- …medical device business units that Leveraged Services team supports. **The Opportunity** The ** Associate Director Regulatory Affairs** will work for our Global ... Regulatory Services division within Leveraged Services. As an Associate Director, the individual is to combine knowledge of scientific, regulatory and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- GRAIL (Menlo Park, CA)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** **** The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Merck (South San Francisco, CA)
- …and non-traditional therapeutics like peptides, novel biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a ... strong, integrated understanding of the strategic elements of drug discovery and development. The Associate Director...regulatory framework to impact strategies and decisions of drug discovery and development teams. + Collaborate with other… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including ... ** Associate Director, Small Molecule Analytical Development** + Lead...drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability for Results… more
- Bristol Myers Squibb (San Diego, CA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** ... policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and...they apply to Regulatory Agencies globally for drug development and approval. + Understanding of scientific content… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... Quality Annual Audit Program. Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development and operational execution of the… more