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Regulatory specialist Jobs in Indianapolis, IN

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Regulatory Manager

Regulatory Manager

State of IndianaIndianapolis, IN, US
Full-time
Begin a fulfilling career with the State of Indiana by joining one of the largest employers in the state, offering a range of opportunities across 60+ agencies. At the state, you'll find competitive...Show moreLast updated: 2 days ago
Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial

Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial

BioSpaceIndianapolis, IN, United States
Full-time
At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 30+ days ago
  • Promoted
Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial

Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial

Eli Lilly and CompanyIndianapolis, Indiana, United States
Full-time
At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 30+ days ago
Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

Katalyst Healthcares & Life SciencesIndianapolis, IN
Full-time
As a Regulatory Affairs Coordinator, you will be part of the compliance department supporting various teams.Investigate, maintain, and manage regulatory product certification claims data, databases...Show moreLast updated: 21 days ago
  • Promoted
Senior Manager, Global Regulatory Affairs

Senior Manager, Global Regulatory Affairs

Otsuka America Pharmaceutical Inc.Indianapolis, IN, United States
Full-time
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for ...Show moreLast updated: 30+ days ago
Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial Products

Advisor / Sr, Advisor - Regulatory Scientist - Global Regulatory Affairs CMC-Parenteral Commercial Products

Eli LillyIndianapolis, IN, United States
Full-time
At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 30+ days ago
  • Promoted
ASSOCIATE VICE PRESIDENT - GLOBAL REGULATORY AFFAIRS, GLOBAL REGULATORY POLICY & STRATEGY (GENE[...]

ASSOCIATE VICE PRESIDENT - GLOBAL REGULATORY AFFAIRS, GLOBAL REGULATORY POLICY & STRATEGY (GENE[...]

The Gerontological Society of America (GSA).Indianapolis, IN, United States
Full-time
At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work worldwide to dis...Show moreLast updated: 2 days ago
  • Promoted
QUALITY & REGULATORY SPECIALIST (HYBRID-IN)

QUALITY & REGULATORY SPECIALIST (HYBRID-IN)

TRIMEDXIndianapolis, IN, United States
Full-time
If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care an...Show moreLast updated: 8 days ago
Research Regulatory Coordinator

Research Regulatory Coordinator

Community Health NetworkIndianapolis, IN
Full-time
Hours : Mon-Fri 8 : 00 am to 5 : 00 pm.Community Health Network has an excellent opportunity available within our Clinical Research Department as a Research Regulatory Coordinator.If you are looking for...Show moreLast updated: 30+ days ago
  • Promoted
ACCREDITATION & REGULATORY CONSULTANT (TEMPORARY)

ACCREDITATION & REGULATORY CONSULTANT (TEMPORARY)

Herzing UniversityIndianapolis, IN, United States
Temporary
To participate in a remote work arrangement, employees must reside in the United States.No remote work arrangement will be considered for working from outside the United States.If you are a current...Show moreLast updated: 6 days ago
  • Promoted
REGULATORY COMPLIANCE PROJECT MANAGER

REGULATORY COMPLIANCE PROJECT MANAGER

Commonwealth Engineers, Inc.Indianapolis, IN, United States
Full-time
Regulatory Compliance Project Manager.The candidate must be a self-starter willing to grow with our company.Applicant must be adaptable, and willing to work in a performance and deadline-driven env...Show moreLast updated: 30+ days ago
Energy Efficiency Regulatory Consultant

Energy Efficiency Regulatory Consultant

ClearesultIndiana
Remote
Full-time
At CLEAResult, we lead the transition to a sustainable, equitable, and carbon-neutral energy-efficient future for our communities and our planet. We do that by creating a people-first culture built ...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Manager, Quality Assurance & Regulatory Compliance

Manager, Quality Assurance & Regulatory Compliance

Neptune MedicalIndianapolis, IN, US
Full-time
Neptune Medical is a venture backed medical device company based in Silicon Valley.We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technolog...Show moreLast updated: 1 hour ago
Sr. Director - Regulatory Affairs

Sr. Director - Regulatory Affairs

LillyRemote, Indiana, United States of America
Remote
Full-time
We’re looking for people who are determined to make life better for people around the world.At Lilly, we unite caring with discovery to make life better for people around the world.We are a global ...Show moreLast updated: 30+ days ago
  • Promoted
PRINCIPAL REGULATORY AFFAIRS SPECIALIST

PRINCIPAL REGULATORY AFFAIRS SPECIALIST

StrykerIndianapolis, IN, United States
Full-time
Work Flexibility : Remote or Hybrid or Onsite.Principal Regulatory Affairs Specialist.This is a Hybrid or Remote role with in office expectations, to be based in. Candidates that reside within the Ce...Show moreLast updated: 3 days ago
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Johnson and JohnsonIndianapolis, IN, United States
Full-time
At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments a...Show moreLast updated: 13 days ago
Regulatory Intelligence Analyst

Regulatory Intelligence Analyst

Veeva Systems IncIndianapolis, IN, United States
Full-time
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in hist...Show moreLast updated: 13 days ago
  • Promoted
Director, Regulatory Nutritional Health & Sustainability

Director, Regulatory Nutritional Health & Sustainability

Elanco Animal Health IncorporatedIndianapolis, IN, US
Full-time
At Elanco (NYSE : ELAN) - it all starts with animals!.As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm an...Show moreLast updated: 30+ days ago
Regulatory Compliance Monitor

Regulatory Compliance Monitor

state of indianaIndianapolis, IN, US
Full-time
Begin a fulfilling career with the State of Indiana by joining one of the largest employers in the state, offering a diverse range of opportunities across 60+ agencies. At the state, you'll find com...Show moreLast updated: 30+ days ago
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Regulatory Manager

Regulatory Manager

State of IndianaIndianapolis, IN, US
2 days ago
Job type
  • Full-time
Job description

Work for Indiana

Begin a fulfilling career with the State of Indiana by joining one of the largest employers in the state, offering a range of opportunities across 60+ agencies. At the state, you'll find competitive compensation, a robust benefits package and a commitment to work-life balance. Most importantly, you'll have the chance to make a real and measurable impact on the lives of Hoosiers across Indiana.

About the Family & Social Services Administration :

The Office of Medicaid Policy and Planning (OMPP) is a division within the Family and Social Services Administration, which receives around 18 percent of the state's budget to ensure vital health care coverage to approximately 1 in 4 Hoosiers. OMPP strives to build programs and processes that enable Hoosiers to live in fully engaged communities and reach their greatest emotional, mental, and physical well-being. Our mission is to support individual and community well-being with effective and efficient programs, remarkable collaborations, measurable impact on individuals and communities, and an energized staff that is fully engaged with this mission.

Role Overview :

This position is responsible for effectively coordinating and implementing the Medicaid legislative requirements and regulatory agenda in alignment with agency and division priorities. This position collaborates with the FSSA legislative team, OMPP Policy team, and other agency and division leadership to effect policy, rule, and law changes. This position manages and oversees the legislative bill review process, serving as the primary point of contact for internal questions and concerns to ensure bill reviews with fiscals are completed, and assisting in generating and collaborating with section leads on various legally mandated reports. This role involves identifying and assessing potential risks to Medicaid concerning policies, procedures, and regulations. The Regulatory Manager proactively helps OMPP achieve its mission by effectively managing the internal complex legislative and legal framework in which the program operates. This position is also responsible for coordinating the civil rights plan and Mental Health Parity requirements. This position also provides support to the Director of Government Affairs.

Salary Statement :

The salary for this position traditionally starts at $75,010.00 but may be commensurate with education or work experience.

A Day in the Life :

The essential functions of this role are as follows :

  • Plan, organize, direct, monitor, and participate in ongoing comprehensive development and implementation of specialized programs and development within the agency.
  • Determine, analyze, identify and implement long-range objectives and specifying the strategies, KPIs, and actions to achieve them.
  • Analyze operations to evaluate performance of the specific program or its staff in meeting objectives or to determine areas of potential cost reduction, program improvement, or policy change.
  • Interpret and explain in-depth and complex policies, rules, regulations, or laws to organizations, government or corporate officials, or individuals.
  • Develop and implement corrective action plans to solve organizational or departmental problems.
  • Prepare and present reports for approval, including those for funding or implementation of services to executive leadership.
  • Develop and oversee program financial or budget activities to fund operations, maximize investments, or increase efficiency.
  • Develop and monitor program requirements to ensure it meets federal and state policies and grants compliance.
  • Develop and supervise training of employees and consultants on program requirements and usage.
  • Develop, coordinator, and deliver communication plans and communications.
  • Preside over, or serve on, boards of directors, management committees, or other governing boards.
  • Recruit, select, onboard, and train employees to ensure role responsibilities and expectations are clearly understood while providing opportunities to continue professional development.
  • Set expectations, measure progress, provide ongoing feedback, and evaluate the performance of employees.  Ensure work adheres to quality standards, deadlines, and proper procedures.
  • Some essential functions of this position may be performed onsite at the agency’s worksite or other assigned worksites while some essential functions of this position may be eligible for work from home authorization in accordance with policy. Remote work authorization is not automatic and is dependent upon operational needs and agency approval.

The job profile is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice.

This position is exempt from overtime compensation for additional work hours which may be required to complete essential functions or other assigned work. Exempt employees may work more than 75 hours in a pay period without additional compensation and must report a minimum of 75 hours per pay period of work hours and / or paid leave taken to receive their base biweekly salary.

What You'll Need for Success :

The ideal candidate in this role should minimally have either

  • a Master’s Degree and 7+ years of experience,
  • or a Bachelor’s Degree and 9+ years of experience, or
  • an Associate’s Degree and 11+ years of experience, or
  • at least 13+ years of experience applying the below, outlined knowledge, skills, and abilities in a similar role.
  • You must meet the following requirements to be considered for employment :

  • Extensive knowledge of the principles, practices, and techniques of a broad area of training and education, including texts and materials developed in the field.
  • Thorough knowledge of the agency or institution’s functions, operations, and purpose.
  • Considerable knowledge of experiential learning techniques.
  • Practical knowledge of laws, rules, and regulations governing mandated training within the agency.
  • Ability to develop, monitor and evaluate broad training programs.
  • Ability to plan and conduct seminars, workshops, and training sessions.
  • Ability to assemble training materials, including writing comprehensive manuals and assembling texts, films, slides, and characters.
  • Ability to establish effective and cooperative working relationships with trainees, other instructors, and the entire agency staff.
  • Effective communication skills.
  • Ability to keep current on new trends, philosophies, and available materials regarding adult education.
  • Ability to delegate work, set clear direction, and manage workflow.
  • Ability to effectively give feedback, provide guidance or corrective action, coach, and develop employee skill sets.
  • Able to perform essential functions with or without reasonable accommodation.
  • Supervisory Responsibilities / Direct Reports :

    This role may provide direct supervision for one or more staff members.

    Benefits of Employment with the State of Indiana :

    The State of Indiana offers a comprehensive benefit package for full-time employees which includes :

  • Three (3) medical plan options (including RX coverage) as well as vision and dental plans
  • Wellness Rewards Program : Complete wellness activities to earn gift card rewards
  • Health savings account, which includes bi-weekly state contribution
  • Deferred compensation 457(b) account (similar to 401(k) plan) with employer match
  • Two (2) fully-funded pension plan options
  • A robust, comprehensive program of leave policies covering a variety of employee needs, including but not limited to :
  • 150 hours of paid New Parent Leave and up to eight weeks of paid Childbirth Recovery Leave for eligible mothers

  • Up to 15 hours of paid community service leave
  • Combined 180 hours of paid vacation, personal, and sick leave time off
  • 12 paid holidays, 14 on election years
  • Education Reimbursement Program
  • Group life insurance
  • Referral Bonus program
  • Employee assistance program that allows for covered behavioral health visits
  • Qualified employer for the Public Service Loan Forgiveness Program
  • Free Parking for most positions
  • Free LinkedIn Learning access
  • Equal Employment Opportunity :

    The State of Indiana is an Equal Opportunity Employer and is committed to recruiting, selecting, developing, and promoting employees based on individual ability and job performance. Reasonable accommodations may be available to enable individuals with disabilities to complete the application and interview process as well as perform the essential functions of a role. If you require reasonable accommodations to complete this application, you can request assistance by contacting the Indiana State Personnel Department at [email protected] .