ZipRecruiter

Log In

1

Regulatory Affairs Program Manager Jobs in Indiana

IDS International

Program Manager

Edinburgh, IN · On-site

They are seeking a Program Manager to oversee the Cybertropolis Technology Environment Platform ... IDS International is an international affairs company specializing in reconstruction and ...

INCOG BioPharma Services

Manager of Packaging

Fishers, IN · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Manager of Device Assembly & Packaging Summary The Manager of Device Assembly & Packaging holds ... Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG ...

INCOG BioPharma Services

Manager of Packaging

Fishers, IN · On-site

$90 - $120/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Manager of Device Assembly & Packaging Summary The Manager of Device Assembly & Packaging holds ... Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG ...

INCOG BioPharma Services

Manager of Packaging

Fishers, IN · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Manager of Device Assembly & Packaging Summary The Manager of Device Assembly & Packaging holds ... Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG ...

INCOG

Manager of Packaging

Fishers, IN

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Manager of Device Assembly & Packaging Summary The Manager of Device Assembly & Packaging holds ... Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG ...

INCOG BioPharma Services

Manager of Packaging

Fishers, IN · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Description Manager of Device Assembly & Packaging Summary The Manager of Device Assembly ... Regulatory Affairs to ensure the DAP program meets current GMP requirements and supports INCOG ...

previous pagenext page

Showing results 21-40

All JobsRegulatory Affairs Program JobsRegulatory Affairs Program Manager JobsRegulatory Affairs Program Manager Jobs in Indiana

Regulatory Affairs Program Manager information

What does a regulatory affairs program manager do?

A Regulatory Affairs Program Manager oversees and coordinates regulatory activities to ensure that a company's products comply with all applicable laws and regulations. They manage submission processes for product approvals, communicate with regulatory agencies, and develop strategies to maintain compliance throughout the product lifecycle. Additionally, they collaborate with cross-functional teams such as research and development, quality assurance, and manufacturing to align regulatory requirements with business objectives. Their role is crucial in minimizing regulatory risks and accelerating the time to market for new products.

What are some typical challenges faced by regulatory affairs program managers when coordinating cross-functional teams?

Regulatory Affairs Program Managers often encounter challenges in aligning the objectives and timelines of different departments such as clinical, quality, and R&D. Balancing varying priorities, managing tight submission deadlines, and ensuring consistent communication between teams are common hurdles. Successful Program Managers proactively foster collaboration, clarify regulatory requirements, and facilitate regular updates to keep projects on track. Being able to anticipate and resolve conflicts, while adapting to evolving regulations, is key to driving effective program execution.

What are the key skills and qualifications needed to thrive as a regulatory affairs program manager, and why are they important?

To thrive as a Regulatory Affairs Program Manager, you need expertise in regulatory guidelines, project management, and a relevant science or healthcare degree. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, strategic communication, and collaborative problem-solving are crucial soft skills in this role. These competencies ensure efficient navigation of complex regulatory requirements, timely submissions, and successful product approvals.

What is the difference between Regulatory Affairs Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Program ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs certification (RAC) preferredUsually holds a bachelor’s degree in life sciences or related field; RAC certification is a plus
Work EnvironmentManages multiple projects, oversees teams, and collaborates with cross-functional departmentsFocuses on preparing and submitting regulatory documents, supporting project teams
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for leadership rolesCommonly employed in similar industries for entry- to mid-level regulatory roles

The Regulatory Affairs Program Manager oversees regulatory strategies and manages teams, while the Regulatory Affairs Specialist handles document preparation and submission. Both roles require relevant credentials and are vital in ensuring compliance within regulated industries.

Is regulatory affairs high paying?

Regulatory Affairs Program Managers typically earn competitive salaries that reflect their specialized knowledge of regulations, compliance, and industry standards. Salaries can vary based on experience, location, and the complexity of the regulatory environment, with many roles offering above-average compensation in the healthcare, pharmaceutical, and biotech sectors.

What are popular job titles related to Regulatory Affairs Program Manager jobs in Indiana?

For Regulatory Affairs Program Manager jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Regulatory Affairs Program Manager jobs in Indiana look for?

The top searched job categories for Regulatory Affairs Program Manager jobs in Indiana are:

What cities in Indiana are hiring for Regulatory Affairs Program Manager jobs?

Cities in Indiana with the most Regulatory Affairs Program Manager job openings:

Regulatory Affairs Program Manager jobs near you

Global Regulatory Lead - Immunology

Eli Lilly and Company

Indianapolis, IN

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

New

Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 63 frontline employees who took The Breakroom Quiz

11th of 86 rated pharmaceutical

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.


About the Role

As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies- from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.

Key Responsibilities

Regulatory Strategy

  • Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle

  • Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategies

  • Lead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriers

  • Ensure local affiliate regulatory plans align to global strategy and business priorities - spanning labeling, risk management, and issues management

US FDA Oversight

  • Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs

  • Drive high-quality communications with FDA that clearly articulate Lilly's scientific position

  • Build and leverage productive relationships with FDA to support product registration goals

Cross-Functional Team Leadership

  • Provide strategic direction to a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling

  • Foster a culture of transparent communication, feedback, and continuous development

  • Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.

  • Represent GRA at stakeholder and governance meetings; mentor GRA personnel

External Engagement

  • Shape the external regulatory environment by building strategic relationships with key external stakeholders

  • Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materials

Minimum Qualifications

  • Advanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development

OR

  • Bachelor's or Masters and 10+ years of experience in regulatory affairs and/or drug development

Additional Preferences

  • Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process

  • Demonstrated experience with regulatory submissions and agency interactions across US, EU, China, and Japan

  • Direct experience in both clinical and CMC regulatory sciences

  • Strong leadership, negotiation, and stakeholder communication skills - including executive-level audiences

  • Proven ability to assess and manage risk in a highly regulated environment

  • Experience in the applicable therapeutic area

Additional Information

  • Travel expected: 10-15%
  • This role is based in Indianapolis, IN and relocation is provided

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.


Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.


Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$169,500 - $248,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

What Eli Lilly and Company employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Eli Lilly logo

About Eli Lilly

Sourced by ZipRecruiter

Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876

View All Eli Lilly Jobs

Apply