- Organon & Co. (Plymouth Meeting, PA)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Organon & Co. (Plymouth Meeting, PA)
- …Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small ... Lead for assigned projects and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. + Lead development… more
- Globus Medical, Inc. (Audubon, PA)
- …Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps ... abreast of regulatory procedures and changes. Recommends strategies for earliest possible...or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience + 5+… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, ... and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs...or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience + 5+… more
- Duquesne Light Company (Pittsburgh, PA)
- …processes, business units and oversight responsibilities. Responsible for assisting the Regulatory Compliance Senior Managers with NERC CIP and O&P compliance ... focus upon always being "audit ready." + Responsible for assisting the Regulatory Compliance Senior Managers in coordinating compliance audits by the Federal Energy… more
- J&J Family of Companies (Spring House, PA)
- …https://www.jnj.com/innovative-medicine We are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our therapeutic ... areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting...and Experience Requirements:** + University/college degree required. Masters or PhD preferred. + At least 8 years of relevant… more
- J&J Family of Companies (Spring House, PA)
- …We are searching for the best talent for an **Associate Director, Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. ... or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally...degree in a scientific discipline is required. Masters or PhD preferred. + At least 10 years of relevant… more
- PNC (Pittsburgh, PA)
- …that PNC Bank's high impact models comply will all applicable internal and regulatory rules and policies. You would additionally: * Serve as subject matter expert ... models are conceptually sound and compliant with the pertinent internal and regulatory policies. Document and communicate results and findings in Audit workpapers… more
- Merck (Harrisburg, PA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... to stay up to date regarding industry trends and diagnostic regulatory requirements. **Essential Job Requirements:** + Develop end-to-end diagnostic strategy in… more