- Merck (West Point, PA)
- …developing analytical methods, assay transfer to GxP laboratories, and supporting regulatory filings including INDs/IMPDs and BLAs.- The successful candidate will be ... responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and manufacturing.- The role will be… more
- Merck (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** + Utilize extensive experience in ... in both development and lifecycle management, ensuring compliance with relevant regulatory standards. + Ensure robust technical plans, risk communication, drive… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** _Strategic Leadership and Project ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality. + Provide Voice of Manufacturing input to early… more
- Highmark Health (Pittsburgh, PA)
- …development including gathering appropriate documents; monitoring particular legal or regulatory developments; engaging in research, cite check and retrieval of ... regulations; and developing information for reviews, reports, accreditation submissions, regulatory filings and court documents. Responsibilities include performing a… more
- PNC (Pittsburgh, PA)
- …Preferred Skills and Qualifications: *Human resources/employment law and regulatory knowledge, including experience with international HR compliance. *Ability ... to senior leadership. Uses knowledge on current laws, rules, and other regulatory requirements and drafts or assesses Compliance Manuals, Front Office materials,… more
- PNC (Pittsburgh, PA)
- …Manuals, policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Coordinates regulatory examinations ... including the coordination of interviews and information requests from regulatory agencies. Independently challenges analyses, reviews and recommendations. +… more
- PNC (Pittsburgh, PA)
- …Manuals, policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Oversees regulatory examinations ... including the coordination of interviews and information requests from regulatory agencies. Independently challenges analyses, reviews and recommendations. +… 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
- Highmark Health (Harrisburg, PA)
- …programs from planning through execution + Strong understanding of the health insurance and health system landscape, including regulatory requirements, market ... improvement, and/or consulting or other relevant experience, preferably within the health insurance industry. + 5 years of experience in Management or leadership… more
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