- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent ...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of ... guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s). + Prepare, coordinate and/or review all CMC and GMP related… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Regulatory Affairs Manager **Location:** Swiftwater, PA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The ... chemical entities. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country … more
- Philips (Murrysville, PA)
- The Regulatory Affairs Program Manager will...You've acquired a minimum of 7+ years' experience in Regulatory Affairs within Global FDA regulated ... and a minimum of 3+ years' experience successfully leading Regulatory Affairs program/project teams in maintaining Global enterprise compliance for Unique… more
- Teva Pharmaceuticals (West Chester, PA)
- …make a difference with. **How you'll spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: + ... * Manager , Regulatory Affairs Date:...* Manager , Regulatory Affairs Date: May 5, 2025...committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without… more
- WuXi AppTec (Philadelphia, PA)
- **Overview** The Government Affairs (GA) Manager will be responsible for the daily management of the US government relations and related stakeholder engagement ... WuXi AppTec's operations in the United States, including legislative and regulatory developments. + Create and review briefing materials (Word, PowerPoint, etc.)… more
- Cardinal Health (Harrisburg, PA)
- …objectives, the Regulatory Compliance Manager will assist with managing Global regulatory compliance across Global Medical Products and Distribution ... of internal and external regulatory policies. Leverage broad knowledge of regulatory affairs , quality management systems and business operations to develop … more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …& Regulatory Compliance domain, which includes: i) Research & Development, ii) Regulatory Affairs , iii) Quality Management and iv) Medical & Scientific ... modeling and data analytics in R&D. + Collaborate with Regulatory Affairs team(s) to align the IT...management, and compliance tracking and to ensure adherence to global regulatory standards. + Collaborate with Quality… more
- J&J Family of Companies (Spring House, PA)
- …https://www.jnj.com/innovative-medicine We are seeking the best talent for a Senior Manager , Global Immunology Communications, Autoantibody Portfolio. This is a ... and rheumatic autoantibody diseases and maternal fetal alloantibody diseases. The Senior Manager will report to the Global Communications Leader, Autoantibody… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... The Global Clinical Lead, Digital and AI reports directly to the Global VP, Clinical Affairs and collaborates closely with the leadership of Clinical… more
- Cardinal Health (Harrisburg, PA)
- …and a host of other adult, pediatric, and neonatal enteral feeding products. The Global Portfolio Manager is an upstream marketing leader for the global ... Health's Medical Products Strategy in the NICU. Support developing business needs by: + Global product manager for NTrainer platform + Serve as product … more
- Pfizer (Collegeville, PA)
- The Senior Manager , Bladder and Renal Carcinoma (RCC), Oncology Medical Affairs will report to the Bladder/RCC Team Lead, US Medical Affairs . This individual ... and other teams in Oncology. Responsibilities of the Senior Manager , Bladder/RCC, Oncology Medical Affairs will include...addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5%… more
- Sumitomo Pharma (Harrisburg, PA)
- …supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs , Quality Assurance, Clinical Operations, and /or SMPA external ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...local regulations. + Collaborate closely with Clinical Operations, CMC, Regulatory Affairs , QA, and PDM to ensure… more
- Fujifilm (Harrisburg, PA)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... and commercialization for the Fujifilm Healthcare Americas Corporation IT portfolio. The Global Product Manager (GPM) is responsible for developing product… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Lead or ... Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical… more
- Santander US (Lebanon, PA)
- Branch Operations Manager , Lebanon, PA Country: United States of America **Your Journey Starts Here:** Santander is a global leader and innovator in the ... procedures and federal and state regulations. May participate in community affairs to enhance the company's visibility and discover new business opportunities.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... working hours across multiple time zones, due to the Global nature of this role. + Some domestic and...activities (desired). + Knowledge of Risk Management practices and regulatory requirements such as FDA QSRs, ISO 13485, ISO… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Clinical Sales Territory Manager will be responsible for the sale of our medical device(s) to appropriately selected, ... targeted accounts and health systems. The Clinical Sales Territory Manager will be responsible for the proper use and...with all Company policies and procedures, including the Quality Affairs policy, and sells products per FDA labelling and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …with other functions both within and outside of Quality, including Regulatory Affairs , Information Technology, Service, Repair, Manufacturing, Commercial teams ... establish and lead execution of plans to optimize our global Post Market Surveillance function. This senior leader will...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more