- The Hershey Company (Hershey, PA)
- …location is Hershey or east coast with travel to Hershey monthly. * Overview* The Director of Regulatory Affairs for the Americas is responsible to assure ... including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively...issues impactful to the business. 3. Lead the cross-functional Regulatory & Scientific Affairs team to continuously… more
- J&J Family of Companies (Harrisburg, PA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... career and life journey, please visit www.careers.jnj.com. **Primary Location** NA- US -Pennsylvania-Horsham **Other Locations** NA- United States , NA-… more
- J&J Family of Companies (Harrisburg, PA)
- …- 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New Jersey ... technology assessments, payor demands) + Lead the preparation of regulatory dossiers for submissions to US FDA....authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on… more
- Merck (Harrisburg, PA)
- …+ Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of ... + 10+ years of experience in device quality, device regulatory affairs , or a related field within...in certain states and cities within the United States . Final determinations with respect to… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 TAU within our ... Global Regulatory Affairs organization, based remotely. + Partners...MS Project, OnePager, Office Timeline, SharePoint etc). **More about us :** At Takeda, we are transforming patient care through… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …you to engage in meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission Support_ reporting to the Nonclinical ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- J&J Family of Companies (Harrisburg, PA)
- …benefits, please go to: - https://www.careers.jnj.com/employee-benefits **Primary Location** NA- US -California-Irvine **Other Locations** NA- United States ... Associate Director , Medical Science Liaison, Cardiac Electrophysiology ( 1...Electrophysiology** . This role is Fully Remote in the United States . At Johnson & Johnson, we… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …acumen and knowledge of key community accounts and academic medical centers across the United States + Ability to quickly assimilate complex information such as ... Value & Access (PVA), Strategic Account Managers and Medical Affairs . + The National Sales Director (NSD)...Regulatory and technical awareness + Possession of valid US Driver's License in good standing **TRAVEL REQUIREMENTS:** +… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US Labeling Operations, EU Labeling ... of 5+ years regulatory and/or related experience. + Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters ... bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, MA, where you will… more
- Prime Therapeutics (Harrisburg, PA)
- …Medicine, Bachelor of Surgery (MBBS) international degree with successful completion of United States based internship and residency (and successful completion ... requesting physicians or ordering providers, when available, within the regulatory time frame of the request by phone or...of United States based fellowship for subspecialists) required.… more
- Prime Therapeutics (Harrisburg, PA)
- …the Affordable Care Act (ACA) + Must be eligible to work in the United States without need for work visa or residency sponsorship **Additional Qualifications** ... are met and business operations are aligned with applicable laws and regulatory guidance. + Provide consultative leadership and direct efforts to communicate… more
- Edwards Lifesciences (Harrisburg, PA)
- …submission experience + The location for this position can be remote within the United States **What else we look for (Preferred)** **:** + Expert understanding ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more