Regulatory And Midstream Experience Preferred. Work collaboratively with internal clients in connection with the following: identify and address regulatory concerns; respond to agency inspection findings, production requests, and FOIA requests; reply to alleged regulatory violations and participate in administrative proceedings.

Provide legal advice regarding pipeline tariff filings and disputes; advise on regulatory issues in complex commercial transactions. Provide legal support for internal clients and industry groups engaged in the legislative process; assess the potential impact of proposed legislation and file comments or amicus briefs to protect the company’s interests.

Establish and maintain productive working relationships with federal, state, and local regulators regarding regulatory compliance and permitting. Strong familiarity and understanding of regulatory language and the ability to quickly identify enforcement deviations.

The MLTC/MAP Compliance Specialist reports into the Director of Regulatory Compliance. Contribute to the annual risk assessment and work plan, ensuring the gathering and provision of MAP/MLTC regulatory compliance related information.

The Kansas Department of Health and Environment has an Environmental Compliance/Regulatory Specialist opening in Topeka. Work with technical staff to prepare regulatory impact statements as directed.

Position Summary ObjectiveThe CMC Regulatory Director, Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participatingleading HA meetings); &or post-approval submissions.

Degree RequirementsMinimum BABS DegreeExperience RequirementsMinimum of 10+ years Pharmaceutical industry experience - prefer knowledge of biotechnology cell therapy products, including multi-disciplined experience, 8+Â years CMC regulatory strategy (biologicscell therapy experience preferred.

Participates in the coordination and completion of multidisciplinary efforts in regard to regulatory preparedness and completion of applications (e.g. Hospital Accreditation and Licensure, CMS Database Forms, ICM completion, measurement of success data, DPH/DOH or CMS corrective action plans, and clinical charter teams.

The ideal candidate will have finance, accounting, capital (Basel and CCAR), regulatory reporting, treasury, risk management, risk and controls, internal audit, data governance and management or regulatory experience; be proactive; able to deal with ambiguity and multi-task; have analytical, strong process and detail orientation; be able to trace through complex processes and regulations; and be able to operate with a high degree of collaboration driving results.

The includes understanding of interdependencies between contributing frameworks (e.g. liquidity risk, interest rate risk, market risk, operational risk, model risk, regulatory reporting, data management, etc.

10 years of Finance, accounting, regulatory reporting, treasury, capital (Basel and CCAR), regulatory, risk and controls, data governance and management, Internal audit, risk management, risk governance experience preferred along with a strong business understanding of Finance, Accounting, Regulatory Reporting, Treasury and Capital processes.

The Clinical Research Regulatory Coordinator I (CRRC) plays a significant role in supporting a timely study start process and is responsible for collecting and providing sponsors with regulatory documents.

This position is also responsible for identifying and implementing EHS strategies, industrial hygiene, site security, safety and chemical regulatory requirements, training on general safety, injury reductions and emissions/waste/water management, including all applicable regulatory and permitting and reporting requirements for regulatory agencies.

The ideal candidate should have experience in handling regulatory and compliance matters before the Texas Public Utility Commission and other state energy regulatory commissions, as well as experience involving matters before or involving the Electric Reliability Council of Texas (ERCOT) or other ISO/RTOs or organized power markets.

Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.