Top 32 Regulatory affairs Jobs in Indianapolis, In

Regulatory Affairs Manager, Companion Diagnostics
Roche —Indianapolis, IN
- $106,100 - $197,000 a year
- Online Application
- Office
- 3 years
- Master's degree
5d
Associate Director, Regulatory Affairs – Biologics
Elanco —Indianapolis, IN
- Full-time
- 5 years
- Bachelor's degree
- Senior level
- Health insurance
- Dental insurance
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
10d
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
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
Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine
Eli Lilly —Indianapolis, IN
- $169,500 - $248,600 a year
- Full-time
- Office
- Master's degree
- 8 years
- Health insurance
- Dental insurance
2h
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
9d
Clinical Research Coordinator
Indiana University —Indianapolis, IN
- Full-time
- Mid-level
- Analysis skills
- University
- Paid parental leave
- Health savings account
Clinical Research Technician
Indiana University —Indianapolis, IN
- Full-time
- Office
- High school diploma or GED
- University
- Paid parental leave
- Health savings account
7d
Clinical Research Specialist
Indiana University —Indianapolis, IN
- $43,908.80 - $47,863.30 a year
- Full-time
- Hybrid work
- Mid-level
- Databases
- University
- Paid parental leave
- Health savings account
GRA Regulatory Delivery Excellence, Clinical Regulatory Associate
Eli Lilly —Indianapolis, IN
- $63,000 - $149,600 a year
- Full-time
- Computer literacy
- Bachelor of Science
- Writing skills
- Health insurance
- Dental insurance
3d
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
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
13d
Clinical Research Technician, Neurology
Indiana University —Indianapolis, IN
- Full-time
- Mid-level
- High school diploma or GED
- University
- Paid parental leave
- Health savings account
Feed Additive Regulatory Specialist
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Office
- Master's degree
- Paid time off
- Parental leave
Project Lead Data Manager
Elanco —Indianapolis, IN
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Office
- Paid time off
- Parental leave
Advisor, Analytical Separations & Biochemistry, Analytical Development - BR&D
Eli Lilly —Indianapolis, IN
- $126,000 - $244,200 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Health insurance
- Dental insurance
GPS Case Management Medical Review Therapeutic Area Leader
Eli Lilly —Indianapolis, IN
- $156,000 - $228,800 a year
- Full-time
- Nursing
- Bachelor of Science
- English
- Health insurance
- Dental insurance
Clinical Research Nurse
Indiana University —Indianapolis, IN
- $77,000.00 - $86,149.20 a year
- Full-time
- Nursing
- Mid-level
- High school diploma or GED
- Paid parental leave
- Health savings account

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Regulatory Affairs Manager, Companion Diagnostics

Roche -
Indianapolis, IN

Apply Now

Job Details

$106,100 - $197,000 a year
5 days ago

Qualifications

Stakeholder management

Full Job Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

At Roche Global Regulatory Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in Companion Diagnostics. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.

The Opportunity

You oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans.
You interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.
You lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
You effectively partner with external and internal stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products.
You have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.
You model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment.
You are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams.

Who you are

You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs
You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
You have demonstrated the ability to manage more complex work and/or at parts of global projects.

Locations
You are local to Indianapolis or Penzberg

No relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Indiana is $106,100 and $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Indianapolis. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this formAccommodations for Applicants.

Apply Now

Refine Your Search

regulatory affairs jobs in indianapolis, in

Regulatory Affairs Manager, Companion Diagnostics

Associate Director, Regulatory Affairs – Biologics

Compliance Specialist (Compliance Data and Report Specialist)

Regulatory Coordinator

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

Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Clinical Data Coordinator (Clinical Research Technician)

Clinical Research Coordinator

Clinical Research Technician

Clinical Research Specialist

GRA Regulatory Delivery Excellence, Clinical Regulatory Associate

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

Multi-Repository Coordinator (Clinical Research Coordinator)

Associate Director, Global Regulatory Advertising and Promotion

Clinical Research Technician, Neurology

Feed Additive Regulatory Specialist

Project Lead Data Manager

Advisor, Analytical Separations & Biochemistry, Analytical Development - BR&D

GPS Case Management Medical Review Therapeutic Area Leader

Clinical Research Nurse

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