Product Regulatory Manager

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Do you have a long-term vision for your career? Are you ready to join a company that aligns with your values and beliefs? At Koch Ag & Energy Solutions (KAES), 90% of our earnings are reinvested in the company so that we can create opportunities and long-term value for our customers, employees and society. Our culture is defined by the Market-Based Management (MBM)® philosophy which guides everyday decision making and provides employees with opportunities to contribute and personally benefit from the value they create.

Koch Ag & Energy Solutions, LLC and its subsidiaries, including Koch Fertilizer, LLC, Koch Agronomic Services, LLC, Koch Energy Services, LLC and Koch Methanol, LLC, are global providers of value-added solutions for the agriculture, turf and ornamental, energy and chemical markets.

Koch Ag & Energy Solutions, LLC. in Wichita, Kansas is seeking a
Product Regulatory Manager to join the Environmental Health and Safety team.
This position is located in
Wichita, KS. This position reports to the Director of Product Stewardship for Koch Ag & Energy Solutions (KAES), and is based in Wichita, KS. The Product Regulatory Manager is responsible for managing new product registrations under US FIFRA, US TSCA and other regimes for additives, fertilizers, pesticides and microbials. As such, the Product Regulatory Manager will work with Research and Development, Product Line, Legal, Public Affairs, Contract Research Organizations (CROs), and government agencies to develop and manage testing programs needed to generate physical, chemical, toxicological, and ecotoxicological data to support product registrations and to support ongoing product risk characterization needs.

A Day In The Life Typically Includes:

* Understand and communicate registration requirements under US TSCA and US FIFRA programs.
* Develop and maintain knowledge of US AHPIS requirements.
* Maintain knowledge of GLP requirements, regulatory guidelines, and relevant SOPs.
* Work with CRO partners, consultants and KAES stakeholders as needed to manage the overall conduct of studies to ensure that all phases of the study are conducted according to the protocol.
* Communicate with study personnel as needed to maintain control over the study, make decisions and act to resolve them.
* Ensure timely and regular communication of study progress to all stakeholders.
* Document, assemble and submit registration dossiers to the appropriate agencies, including master labels, bridging discussions and data summaries, as appropriate.
* Manage US EPA and other Agency relationships to ensure timely, successful action is taken on registration submittals.
* Manage complex projects and provide timely deliverables. Keep projects on task and maintain a high-level of attention to detail.
* Work with CRO Quality Assurance Units (QAU) and the Director to ensure that raw data, Final Reports, and other study-related information are appropriately reviewed.
* Ensure KAES stakeholders understand and appropriately manage product-related health, safety, and environmental risks commensurate with the KAES risk profile.
* Provide project management for ongoing compliance needs, including but not limited to implementation of a formulation database and other projects as needed.

What You Will Need:

Basic Qualifications:

* 3
+ years experience in regulatory compliance or laboratory oversight of agrochemicals, pharmaceuticals, pesticides, industrial chemicals, fertilizer additives, plant growth regulators or soil inoculant registrations
* Experience with EPA and OECD testing requirements
* Experience with chemicals, pesticides or product research and registration
* BS in Chemistry, Biology, Toxicology, Microbiology, Public Health or other relevant scientific subject

What Will Put You Ahead?

Preferred Qualifications:
* Objective, non-comparative ideal skills
* Experience with agrochemical R&D including basic agronomy, greenhouse and research lab practices, and product development
* Experience with toxicological testing, hazard classification and labeling
* GLP Study Director or Sponsor experience
* Masters Degree or PhD in Chemistry, Biology, Public Health or other relevant scientific subject

Want to learn more about KAES?

This role is not eligible for visa sponsorship.

Salary and benefits commensurate with experience.
We are an equal opportunity employer. Minority/Female/Disabled/Veteran
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.

This employer uses E-Verify. Please visit the following website for additional information: http://www.kochcareers.com/doc/Everify.pdf

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Regulatory Specialist – Rotational Development Program

Medline Industries has an immediate expansion opportunity for a Regulatory Affairs Specialist-Rotational Development located in the Northfield, IL headquarters. This position will primarily focus on regulatory affairs/compliance issues related to the wholesale distribution and manufacturing of healthcare products, including but not limited to pharmaceuticals and medical devices. This position will also provide opportunities to cross-train and work on special projects related to topics such as, regulatory operations, product labeling and marketing, new product development, premarket approval applications, and quality assurance. Excellent opportunity for professional growth and development of your healthcare regulatory affairs career with Medline by learning the skills required for a variety of regulatory affairs functional areas. We are seeking a dynamic, hardworking professional with a desire to work for a fast-paced, large corporate organization. In addition to exceptional leadership potential and analytical skills, you must have a “roll-up your sleeves” attitude.

Responsibilities include:
* Under general supervision, ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements (labeling, licensing, registration, listing and/or submission for clearance or approval Medline facilities and/or product).
* Review and approve promotional literature in paper or electronic format using information provided by product managers, vendors, divisional QA’s, sales and marketing.
* Review and approve product labeling using information provided by product managers, vendors, divisional QA’s and marketing.
* Complete and maintain Medline or vendor product licenses, registrations or listings as required, interacting with state, federal or international regulatory authorities and internal customers to accomplish.
* Determine the requirements for and complete Medline product submissions for regulatory authority clearance or approval (to market a new product as a drug, medical device, food, dietary supplement, biological, cosmetic or commodity item) by working with vendors, internal customers and consultants as needed.
* Communicate requirements of regulations to internal or external customers, or to vendors.
* Initiate or maintain relevant procedures or SOP’s, updating as needed and training when required.
* Train new employees/product managers on labeling requirements as needed.
* Conduct internal audits (files, processes, databases, etc.).
* Assign NDC (National Drug Code) numbers, NHRIC (National Health Related Item Code) numbers, and any other standardized numbers as required.
* Maintain department databases, logs and files.

Requirements include:
* Bachelor’s Degree (biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences) AND at least 2 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area preferred.

OR
* High school diploma or equivalent AND at least 5 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area.
* Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within.
* Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products.
* Experience evaluating information to determine compliance with standards, laws, and regulations.
* Advanced skill level in SAP and AS400.
* Advanced skill level in Excel, Word.

Preferred requirements include:
* At least 1 year of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
* Experience preparing and filing complete A/NDA’s, Supplements, Amendments and Annual Reports to FDA.
* Experience applying knowledge of the CFR, FDA/ICH guidelines and cGMP’s as they pertain to pharmaceuticals.
* Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products.

Medicare Regulatory & Reimbursement Specialist

The Specialist will be responsible for the preparation of Medicare Cost Reports and providing consulting and compliance services regarding Medicare to entities within the Mayo Clinic enterprise. Travel is required, occasionally overnight. In addition, the specialist will lead or work collaboratively on multi-disciplinary workgroups and projects related to reporting initiatives, benchmarking, research and analysis, gathering data, financial impact modeling, audits, compliance initiatives, and other customer requested projects. This position will also actively communicate and present reports and educational materials to various audiences. The position will also interact with external auditors for the Medicare program.Bachelor’s degree and a minimum of 3 years experience in preparing or auditing Medicare cost reports OR a 2 year degree with 6 years experience in health care finance, business, finance, or systems, with a minimum of 3 years experience in Medicare cost report audit or preparation OR a high school degree and 8 years experience in health care finance, business, finance, or systems with a minimum of 3 years experience in preparing or auditing Medicare cost reports. A positive attitude, strong interpersonal skill, aptitude for precisian, attention to detail and strong person computer skill are required. Proficiency with accurate data entry on PC is essential. Ability to handle multiple tasks, analyze information and proven telephone, oral and written communications skills. In addition, familiarity with internal billing systems (DSS, Focus, MRIS, etc) is preferred.