ZipRecruiter

Log In

1

Regulatory Affairs Program Manager Jobs in Indiana

Aequor

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Responsible for ... manages the development of package inserts Reviews and evaluations promotion and advertising ...

Roche

Regulatory Affairs Project Manager

Indianapolis, IN · On-site +1

$93K - $172K/yr

You have a Bachelor's or Master's degree in Life Science, Data Science or related subject. * 5 years of experience in regulatory, development, clinical affairs, quality, or program management in IVD ...

Actalent

Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $55/hr

Write and manage the development, review, and maintenance of package inserts for medical devices ... Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a ...

Becton, Dickinson and Company

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

next page

Showing results 1-20

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

Regulatory Affairs Specialist

Aequor

On-site

Full-time

Posted 4 days ago

Job description

Regulatory Affairs Specialist 1 Year Contract Warsaw, IN (100% Onsite) Duties Responsible for assisting the team with regulatory filings as necessary to market our client's products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process. Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. Respond to requests from foreign government and/or distributors as needed Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products Evaluate risk of proposed regulatory strategies; may offer solutions Reviews proposed labeling for compliance with applicable global regulations Writes and manages the development of package inserts Reviews and evaluations promotion and advertising material for compliance with applicable regulations Reviews proposed product changes for impact on regulatory status of the product Communicates with regulatory and governmental agencies with supervision Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills Strong writing, communication, and interpersonal skills Strong attention to detail; ability to multi-task and balance competing priorities Knowledge of overall business environment, the orthopaedic industry, and the marketplace Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels Knowledge of FDA, EU, and other regulatory body regulations Ability to identify risk in Regulatory strategies Strong problem solving skills Effective negotiating skills Basic computer skills, including Microsoft Office Suite Education Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred A minimum of one year of experience in orthopaedic or medical device industry preferred A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required Regulatory Affairs Certification (US or EU) preferred A combination of education and experience may be considered #TechAM Salary: . Date posted: 08/26/2026

Apply