- PNC (Pittsburgh, PA)
- …be performed remotely, at manager's discretion. The opportunity lies within PNC's Regulatory Reporting department, specifically the Finance Data Submissions team ... success. As a Sr. Business Analytics Consultant within PNC's Regulatory Reporting organization, housed within the Office of the...for filing the Federal Reserve FR Y14Q/M CCAR data submissions . This role is an opportunity to navigate the… more
- Sumitomo Pharma (Harrisburg, PA)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- Globus Medical, Inc. (Audubon, PA)
- …medical device development and registration of products + Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... PMA submissions a plus + Experience assessing regulatory impact of product/process changes + Experience reviewing labeling, promotional literature, etc. +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Organon & Co. (Plymouth Meeting, PA)
- …to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions . This includes assessing CMC changes during development and ... manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage… more
- West Pharmaceutical Services (Exton, PA)
- …Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. ... Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746...+ Author and review US, EU, and additional international submissions with guidance for new products and product changes… more
- United Therapeutics (Harrisburg, PA)
- …managing documentation and timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are ... the ESG portal + Proven track record in successfully navigating regulatory submissions + Proven ability to lead and influence data-driven strategy planning… more
- System One (Malvern, PA)
- …strategy and manage the creation, review, and edit of documentation for US and OUS regulatory submissions . + Manage and maintain ongoing submissions such as ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type:...Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and Medical Affairs SOPs to ensure full compliance… more
- KeyBank (Pittsburgh, PA)
- …a critical part in ensuring the completeness, accuracy, and timeliness of regulatory submissions by enhancing control frameworks, supporting data governance ... 44114 **Position Summary:** Key is seeking a detail-oriented and proactive Regulatory Reporting Governance Senior Analyst to support the governance, oversight, and… more