- Astellas Pharma (Westborough, MA)
- …for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements. + Ability to interpret regulatory rules, ... qualification and validation procedures and practices in accordance with global regulatory bodies (FDA, EMA, ICH, Japan guidance), Astellas policies and procedures… more
- Lundbeck (Deerfield, IL)
- …sign-off authorization. + Ensures all activities are following ICH, and other international regulatory guidelines and relevant GCPs and SOPs. + Participates ... thought leaders. + Professional society membership(s) relevant to migraine/headache. + Regulatory knowledge and exposure, including experience with international … more
- Catalent Pharma Solutions (San Diego, CA)
- …International cGMP regulations and experience working directly with the local and international regulatory agencies; + Must have a demonstrable record of ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development… more
- AbbVie (Irvine, CA)
- …management practices and long term planning skills. + Excellent knowledge of various international regulatory and GMP requirements. + Must be goal oriented, able ... products and can represent the company in discussions with regulatory agencies. Due to nature of the projects and...AbbVie's pharmaceutical Operations ($1B) to minimize back orders and regulatory risks. + Each technical function is responsible for… more
- Nestle (Arlington, VA)
- …assigned international regions. + Oversee export operations: Coordinate international orders, regulatory requirements, Customer Order Fulfillment (COF), and ... + Collaborate cross-functionally: Work with finance, CD, supply chain, legal, and regulatory teams to align international strategies with overall business… more
- Terumo Medical Corporation (Somerset, NJ)
- …full compliance with US Food and Drug Administration (FDA) regulations, international regulatory requirements, company policies, operating procedures, and ... position provides subject matter expertise in labeling requirements across US and international markets and ensures compliance with FDA, Terumo, and global … more
- Abbott (Santa Clara, CA)
- …of the Global Regulatory Landscape: Bring deep knowledge of international regulatory requirements to guide operational decisions. **Qualifications** + ... also have access to: + Career development with an international company where you can grow the career you...study execution. + Drive strategic execution of clinical and regulatory goals across diverse therapeutic areas. + Manage timelines,… more
- SAP (New York, NY)
- …teams to ensure consistency of messaging across regions and alignment on international regulatory narratives Act as SAP's senior spokesperson when appropriate, ... Role** The Global Co-Leader of Public Relations leads and mentors an international team dedicated to proactive corporate, financial, and product storytelling while… more
- Fujifilm (Holly Springs, NC)
- …industry. OR * Proven Leadership Experience * Experience with US and international regulatory standards and ICH guidelines especially with regards to ... (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well… more
- Oracle (Santa Clara, CA)
- …a plus. **Technical Expertise:** * Basic understanding of EMC fundamentals and international regulatory frameworks. * Familiarity with lab equipment, test ... international standards for Electromagnetic Compatibility (EMC) and regional regulatory requirements. The successful candidate will work closely with senior… more