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Regulatory Affairs Program Manager Jobs in Indiana

The Regulatory Affairs Associate Director, Globalization is responsible for alignment and execution ... Weight management programs * Gastrointestinal health program * Substance use management program

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

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

Manager, Regulatory Affairs

AES Corporation

Indianapolis, IN • On-site

$90 - $130/hr

Other

Re-posted 9 days ago


AES Corporation rating

7.4

Company rating: 7.4 out of 10

Based on 36 frontline employees who took The Breakroom Quiz

37th of 53 rated energy and utility


Job description

Are you ready to be part of a company that's not just talking about the future, but actively shaping it? Join The AES Corporation, the largest US-based global power company with a team of 8,300 employees across 12 countries.AES has been ranked #1 by BloombergNEF in renewable energy sales to corporations in the US and Americas for five consecutive years, providing electricity for millions of people worldwide.We are proud to foster a strong workplace culture, earning prominent positions in Great Place to Work rankings across the markets where we operate. AES was also named one of the World’s Most Ethical Companies for the 13th consecutive year in 2026, highlighting our dedication to integrity, transparency, and responsible business practices.Our spirit of innovation continues to earn industry recognition. AES is the only seven-time winner of the Edison Electric Institute’s Edison Awards in the twenty-first century, a distinction honoring global leadership in advancing the electric power industry.If you're ready to be part of a company that's not just adapting to change, but driving it, AES is the place for you. We're not just building a more sustainable future, we're powering it. Apply now and energize your career with a true leader in global energy.Under limited supervision, the Manager, Regulatory Affairs is responsible for leading a small team responsible for designing tariffs and prepare testimony to the Indiana Utility Regulatory Commission coordinating filings with and testifying before the Indiana Regulatory Commission providing financial, technical, and regulatory analysis supporting senior management assimilating technical and economic information into rate design, and reviewing and providing comment on proposed State and Federal legislation and proposed rules and regulations.ResponsibilitiesSupervises, leads and trains rates and regulatory analysts in the group, focusing on individual development and positive team cultureReviews and provides comments on proposed State and Federal legislation and proposed rules and regulations.Designs tariffs and prepares testimony to the Indiana Utility Regulatory Commission.Coordinates filings with and testifies before the Indiana Regulatory Commission.Provides financial, technical, and regulatory analysis supporting audits, regulatory filings and senior management.Assimilates technical and economic information into rate design.Supports settlement strategy and negotiations.Leads and prepares analysis and research to support leadership decision-making and strategyRequired Experience and Skills:Bachelors degree required.Graduate degree preferred.CPA certification is highly valued.A licensed engineering background or an MBA is considered a strong asset.Seven to ten years of related utility experience.Computer proficiency required to include Excel, Word, PowerPointEffective written and verbal communication skills, including experience with written testimony before the CommissionLeadership / direct supervisory experience / mentoring & trainingResults oriented, self-motivated, and able to work with limited direct supervisionAES is an Equal Opportunity Employer who is committed to building strength and delivering long-term sustainability through diversity and inclusion. Respecting all backgrounds, differences and perspectives enables us to improve the lives of our people, customers, suppliers, contractors, and the communities in which we live and work. All qualified applicants will receive consideration for employment without regard to sex, sexual orientation, gender, gender identity and/or expression, race, national origin, ethnicity, age, religion, marital status, physical or mental disability, pregnancy, childbirth, or related medical condition, military or veteran status, or any other characteristic protected under applicable law. E-Verify Notice: AES will provide the Social Security Administration (SSA) and if necessary, the Department of Homeland Security (DHS) with information from each new employee's I-9 to confirm work authorization. #J-18808-Ljbffr

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