- Cardinal Health (Harrisburg, PA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations uses specialized technology and knowledge ... and compile paper and electronic documents related to the pharmaceutical industry regulatory submissions throughout each phase of drug development and though… more
- Merck (North Wales, PA)
- …Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions , Strategic Thinking {+ ... **Job Description** The Submissions Content Source Management Business Operations Lead is...Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… 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
- Cardinal Health (Harrisburg, PA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... to provide services in technical writing, scientific data verification, and basic regulatory submissions within the discipline of chemistry, manufacturing, and… 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
- Merck (North Wales, PA)
- …Regulatory Compliance, Regulatory Reviews, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions **Preferred Skills:** ... advisory committee meetings and may include a speaking role. + Coordinate regional regulatory strategy and submissions through collaboration with Regulatory … more
- Organon & Co. (Plymouth Meeting, PA)
- …on assigned products for all internal and external stakeholders to ensure timely regulatory submissions , quality and compliant labeling documents, and to support ... with local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally. **Required Education, Experience and… 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
- 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