Top 51 Regulatory affairs Jobs in Indiana

Regulatory Affairs Manager
Zimmer Biomet —Warsaw, IN
- $113,407 - $141,759 a year
- Full-time
- Anatomy knowledge
- Computer literacy
- Research
- Wellness program
Regulatory Affairs Manager, Companion Diagnostics
Roche —Indianapolis, IN
- $106,100 - $197,000 a year
- Online Application
- Office
- 3 years
- Master's degree
1d
Regulatory Affairs Specialist
OrthoPediatrics —Warsaw, IN
- Full-time
- Anatomy knowledge
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Regulatory Coordinator
Engineered Medical Syst —Indianapolis, IN
- $60,000 - $70,000 a year
- Full-time
- Ability to walk for extended periods
- English
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Global Regulatory Advertising and Promotion
IQVIA —Indianapolis, IN
- $103,600 - $288,600 a year
- Full-time
- Remote
- 5 years
- Master's degree
- Bachelor's degree
- Work from home
8d
Compliance Specialist (Compliance Data and Report Specialist)
Indiana University —Indianapolis, IN
- $65,000 - $70,000 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Paid parental leave
- Health savings account
5d
Associate Director, Regulatory Affairs – Biologics
Elanco —Indianapolis, IN
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Health insurance
- Dental insurance
Clinical Research Coordinator
Indiana University —Indianapolis, IN
- Up to $61,200 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- University
- Paid parental leave
- Health savings account
Internal Medicine Field Medical, Director, non-MD
Pfizer —Indiana
- $176,600 - $294,300 a year
- Online Application
- Up to 50% travel
- 5 years
- Bachelor of Science
- Paid holidays
- Relocation assistance
5d
Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy
Eli Lilly —Indianapolis, IN
- $169,500 - $248,600 a year
- Full-time
- Office
- Master's degree
- 8 years
- Health insurance
- Dental insurance
Multi-Repository Coordinator (Clinical Research Coordinator)
Indiana University —Indianapolis, IN
- $48,235.20 - $57,353.00 a year
- Full-time
- Hybrid work
- Mid-level
- Analysis skills
- University
- Paid parental leave
- Health savings account
11d
Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK
サイネオス・ヘルス —Indiana
- $80,600 - $175,700 a year
- Remote
- 5 years
- Travel
- Mentoring
- Employee stock purchase plan
- Health insurance
3d
Feed Additive Regulatory Specialist
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Office
- Master's degree
- Paid time off
- Parental leave
Clinical Research Specialist
Indiana University —Indianapolis, IN
- Full-time
- Mid-level
- Databases
- University
- Paid parental leave
- Health savings account
Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides
Eli Lilly —Indianapolis, IN
- $148,500 - $257,400 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Manufacturing
- Health insurance
- Dental insurance
Clinical Data Coordinator (Clinical Research Technician)
Indiana University —Indianapolis, IN
- Full-time
- Mid-level
- Office
- High school diploma or GED
- Paid parental leave
- Health savings account
4d
Project Lead Data Manager
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Office
- Paid time off
- Parental leave
Clinical Research Technician
Indiana University —Indianapolis, IN
- Full-time
- Office
- High school diploma or GED
- University
- Paid parental leave
- Health savings account
2d
Assistant Research Professor
Indiana University —Indiana
- Medicine
- 5 years
- Residential
3d
Senior Biologist
Eli Lilly —Indianapolis, IN
- $65,250 - $169,400 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- US work authorization
- Health insurance
- Dental insurance
3d

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Regulatory Affairs Manager

Zimmer Biomet -
Warsaw, IN

Apply Now

Job Details

Full-time
$113,407 - $141,759 a year

Benefits

Wellness program

Qualifications

Computer literacy
Data-driven problem-solving
Stakeholder relationship building
Stakeholder management

Full Job Description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Responsible for managing support of regulatory affairs systems used to support the Zimmer Biomet RA teams. This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals.

How You'll Create Impact

Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions

Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates

Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research

Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products

Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products

Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status

Writes, manages, and approves the development of package inserts

Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations

Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization

Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them

Provides training and guidance to entry-level associates, interns, specialists, and project managers

Communicates with Regulatory/Governmental agencies

Responsibility for oversight and prioritization of departmental tasks and projects

Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development

Miscellaneous responsibilities as assigned

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports
Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail
Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities
Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace; strong product knowledge
Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as applicable
Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization
Ability to identify and asses business risks to develop Regulatory strategy
Mastery anatomic knowledge
Ability to handle increasing levels of responsibility
Ability to build and lead a strong RA team; ability to lead and influence others
Strong computer skills
Ability to negotiate with regulatory agencies, management, and other groups as necessary
Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable
Drive regulatory strategy and execution for new product introductions, ensuring timely market access and compliance throughout the product lifecycle.
Serve as the primary Regulatory Affairs liaison for IT-related initiatives, partnering closely with cross-functional teams to represent regulatory requirements and business needs.
Evaluate emerging technologies, including Artificial Intelligence (AI) applications, and provide regulatory input and guidance on their implementation.
Collaborate with Project Management Office (PMO) teams to ensure effective planning, prioritization, and execution of strategic initiatives.
Lead and develop a team of regulatory professionals, providing coaching, feedback, and performance management for a team of approximately six - seven direct reports.
Analyze and communicate regulatory metrics, trends, and performance indicators using data visualization tools such as Power BI.Prepare and deliver executive-level presentations and communications, including the development of PowerPoint presentations for leadership and cross-functional stakeholders.

Your Background

Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
Advanced degree strong preferred
6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU
A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred
Regulatory Affairs Certification (US or EU) preferred
Manage regulatory change initiatives, including the planning, coordination, and execution of regulatory submissions related to product, process, and system changes.
A combination of education, experience, leadership, strategy and RA influence may be considered
Support the implementation, enhancement, and governance of regulatory IT systems and digital solutions.
Lead the intersection of Regulatory Affairs and IT by serving as the key regulatory representative for technology-driven initiatives. This role blends regulatory management, technical oversight, and project leadership to drive system improvements, support digital transformation efforts, and ensure regulatory requirements are effectively translated into IT solutions and business processes.
PMO or project management experience preferred.
Familiarity with regulatory information management systems and digital transformation initiatives, IT tools for regulatory.
Proficiency with Power BI and Microsoft PowerPoint.Excellent communication, stakeholder management, and cross-functional leadership skills.
Proven people leadership experience managing direct reports.

COMPENSATION

Salary Range 113,407.00 - 141,759.00 USD/annual

Physical Requirements

Travel Expectations

Up to 20%

This is a fully remote position; however, occasional travel is required based on business needs.

While this is a remote position, strong preference will be given to candidates located in or near Warsaw, Indiana, USA for our office.

EOE/M/F/Vet/Disability

Apply Now

Refine Your Search

regulatory affairs jobs in indiana

Regulatory Affairs Manager

Regulatory Affairs Manager, Companion Diagnostics

Regulatory Affairs Specialist

Regulatory Coordinator

Associate Director, Global Regulatory Advertising and Promotion

Compliance Specialist (Compliance Data and Report Specialist)

Associate Director, Regulatory Affairs – Biologics

Clinical Research Coordinator

Internal Medicine Field Medical, Director, non-MD

Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy

Multi-Repository Coordinator (Clinical Research Coordinator)

Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK

Feed Additive Regulatory Specialist

Clinical Research Specialist

Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides

Clinical Data Coordinator (Clinical Research Technician)

Project Lead Data Manager

Clinical Research Technician

Assistant Research Professor

Senior Biologist

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