Top 6484 Jobs in Bloomington, IN

Regulatory Affairs Specialist
Singota Solutions —Bloomington, IN
- Full-time
- Hybrid work
- Mid-level
- Microsoft Office
- Bachelor's degree
- Health savings account
- AD&D insurance
14d
Business Development Executive
Singota Solutions —Bloomington, IN
- Full-time
- Background check
- 5 years
- Bachelor of Science
- Health savings account
- AD&D insurance
5d
EDI Analyst
FOR BARE FEET LLC —Martinsville, IN
- $60,000 - $65,000 a year
- Full-time
- Background check
- ERP systems
- Mid-level
- Dental insurance
- 401(k)
Quick Apply
7d
Purdue Extension Office Manager
BROWN COUNTY GOVERNMENT —Nashville, IN
- $38,985 a year
- Full-time
- Mid-level
- Office
- Data entry
- Health savings account
- Health insurance
Quick Apply
3d
Administrative Assistant
Curry Auto Center, Inc. —Bloomington, IN
- $15 an hour
- Full-time
- Clean driving record
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Administrative Assistant
Indiana University —Bloomington, IN
- Full-time
- Classroom
- Mid-level
- Office
- Paid parental leave
- Health savings account
Part-Time Assistant Prints Drawings and Photographs Preparator, Eskenazi Museum of Art
Indiana University —Bloomington, IN
- $22 an hour
- Part-time
- Maintenance
- High school diploma or GED
- University
- Paid parental leave
- Health savings account
4d
Merchandise and Stocking Associate
Sam's Club —Bloomington, IN
- $18 - $26 an hour
- High school
- Sales
- Merchandising
- Paid jury duty
- Disability insurance
Pharmaceutical Manufacturing Operator
Simtra BioPharma Solutions —Bloomington, IN
- $20.00 - $26.50 an hour
- Full-time
- Background check
- Sanitation
- Pass drug screening
- Paid parental leave
- AD&D insurance
Quick Apply
Sporting Goods Associate/Lead @ Play It Again Sports Bloomington IN
Style Encore Bloomington —Bloomington, IN
- Up to $14 an hour
- Part-time
- Ability to walk for extended periods
- Cleaning
- In-person
- Employee discount
- Opportunities for advancement
Quick Apply
3d
Homeless Shelter Monitor Part-time 3rd shift
Beacon Inc —Bloomington, IN
- $16.66 an hour
- Part-time
- Background check
- Cleaning
- Fair chance
- Health insurance
- Dental insurance
Quick Apply
Unarmed Security Officer
MSI Security —Bloomington, IN
- From $15 an hour
- 8 hour shift
- Background check
- 18 years or older
- CPR Certification
- Health insurance
- Paid time off
Quick Apply
Relationship Banker II (Bloomington Whitehall Branch)
Regions —Bloomington, IN
- $43,814.19 - $52,402.00 a year
- Overtime
- Ability to walk for extended periods
- Computer literacy
- Mid-level
- Health savings account
- Health insurance
Server
Gentry Park Senior Living (2) —Bloomington, IN
- Full-time
- Hospitality
- High school diploma or GED
- Criminal background check
- Health insurance
- Dental insurance
Quick Apply
Management Trainee - Bloomington
Enterprise Mobility —Bloomington, IN
- $50,000 a year
- Urgently hiring
- Business development experience
- Driver's License
- Bachelor's degree
- Profit sharing
- Health insurance
Leasing Consultant Part-Time (The Beverly)
Buckingham Companies —Bloomington, IN
- Part-time
- Entry level
- Paid time off
12d
Eligibility Assistant - Front Desk
DFR —Bloomington, IN
- $15 an hour
- Full-time
- Office
- Administrative experience
- High school diploma or GED
- Paid time off
4d
Pharmaceutical Unarmed Security Officer
MSI Security —Bloomington, IN
- From $20 an hour
- Part-time
- Background check
- CPR Certification
- Military
Quick Apply
Bus Driver
Bloomington Transit —Bloomington, IN
- $20.59 - $30.28 an hour
- Weekends as needed
- Clean driving record
- English
- 21 years or older
- Paid training
- Opportunities for advancement
Quick Apply
6d
Office Coordinator
Coca-Cola Consolidated, Inc. —Bloomington, IN
- From $18.17 an hour
- Data analysis skills
- Research
- Office
- Employee stock purchase plan
- Health insurance
8d

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Jobs jobs near Bloomington, IN

Regulatory Affairs Specialist

Singota Solutions
Bloomington, IN

Apply Now

Job Details

Full-time
14 days ago

Benefits

Health savings account
AD&D insurance
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Life insurance

Qualifications

Microsoft Office
Attention to detail
Pharmaceutical company experience
Regulatory affairs
Productivity software
Standard operating procedures (SOPs)
Manufacturing company experience
Technical Proficiency

Full Job Description

Why join Team Singota?

We pride ourselves on a high-trust, high-accountability environment where we lift each other up. When you join Singota, you are a part of a team that respects, supports, and values its people. We celebrate wins together, brainstorm solutions together, and genuinely enjoy the work we do. The result? A team that’s not just efficient, but also passionate, dedicated, and fun to work with.

Job Title: Regulatory Affairs Specialist

Department: QA/RA

Reports to: Sr. Regulatory Affairs Specialist

Location: Bloomington, IN (Hybrid)

Position Type: Full-time, Exempt, 40 hr/wk

General Description:

The Regulatory Affairs Specialist assists in the support and execution of regulatory affairs and compliance programs at Singota. This role will be responsible for supporting day-to-day regulatory operations, including providing regulatory guidance and support to Singota’s diverse client base. The Regulatory Affairs Specialist will support the organization by providing CMC regulatory support, preparing and managing regulatory documentation, and coordinating with internal and external technical teams and stakeholders to ensure compliance with applicable regulatory standards and guidance. The role also includes supporting the implementation and maintenance of procedures to verify that the regulatory program remains effective and efficient. This is a remote position; however, routine onsite presence will be required as needed to support audit activities and other business requirements.

Key Responsibilities:

1. Conduct ongoing regulatory surveillance to proactively identify and address upcoming regulatory changes and collaborate with relevant departments to identify and implement necessary changes.

2. Assist in the management of Singota licensing, certifications, and registrations, including but not limited to domestic and foreign agencies, regulatory bodies, and government agencies.

3. Assist in commercial/controlled substance license evaluations of Singota’s supply chain partners to ensure compliance with Drug Supply Chain Security Act (DSCSA) requirements.

4. Support internal compliance with applicable regulatory requirements (e.g., FDA, MHRA, EMA, ICH, etc.)

5. Collaborate with internal departments in addressing regulatory topics and provide guidance as needed.

6. Assist with impact assessments for manufacturing, analytical, facility, and supplier change notifications.

7. Interface with clients during routine project meetings to provide regulatory guidance and support.

8. Coordinate information requests between Client(s) and internal technical functions.

9. Provide support during client and regulatory audits of Singota, ensuring regulatory and quality standards are met.

10. Provide support in preparation of client regulatory submission documentation, as applicable, including but not limited to Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs) in accordance with regulatory requirements.

11. Provide support in preparation and submission of facility Drug Master File (DMF), as well as annual product review(s) (APRs), and annual reporting requirements.

12. Author and review site procedures and specifications to verify adherence to applicable regulations.

13. Design and deliver training sessions and refresher courses to communicate regulatory changes to key stakeholders across the organization.

14. Assist with compilation, formatting, and quality verification of regulatory submissions to ensure accuracy and completeness.

15. Assist in the development and management of audit responses, working collaboratively across functions and ensuring accurate documentation and management of all audit records.

16. Participate in the preparation, evaluation, and modification of client Quality Agreements

17. Provide primary ownership of deviations, CAPAs and change controls as needed.

18. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures.

19. Contribute to the assessment of business opportunities by evaluating potential projects from a regulatory standpoint as part of a cross-functional team.

20. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.

Skills and Physical Activity Requirements:

1. Must possess excellent written and oral skills.

2. Demonstrate a positive attitude and professional presence within the workplace and when interacting with external parties

3. Must possess strong organizational skills with the ability to manage competing priorities across multiple client programs.

4. Individual must have a strong attention to detail for review and interpretation of quality and regulatory documentation/submissions.

5. Ability to follow established standard operating procedures and established processes; escalating issues appropriately.

Education and Work Experience Requirements:

1. Bachelor’s degree or equivalent experience – science or regulatory related field preferred.

2. Minimum 3-5 years pharmaceutical experience is required, preferably in a quality/regulatory role.

3. Experience with regulatory submissions/regulatory surveillance is desired.

4. Proficiency in Microsoft Office; familiarity with document management system(s) and eQMS platforms is desired

Benefits:

Dental insurance - effective day one of employment

Health insurance - effective day one of employment

Vision insurance - effective day one of employment

Health savings account

Life & AD&D insurance

Short & long term disability

Paid time off & holidays

Employee Assistance Program

Tuition assistance

401(k) with company match

Singota Solutions is an Equal Opportunity Employer

Job Type: Full-time

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance

Experience:

life sciences: 3 years (Required)

Ability to Commute:

Bloomington, IN 47404 (Required)

Work Location: Hybrid remote in Bloomington, IN 47404

Apply Now

Refine Your Search

jobs in Bloomington, IN

Regulatory Affairs Specialist

Business Development Executive

EDI Analyst

Purdue Extension Office Manager

Administrative Assistant

Administrative Assistant

Part-Time Assistant Prints Drawings and Photographs Preparator, Eskenazi Museum of Art

Merchandise and Stocking Associate

Pharmaceutical Manufacturing Operator

Sporting Goods Associate/Lead @ Play It Again Sports Bloomington IN

Homeless Shelter Monitor Part-time 3rd shift

Unarmed Security Officer

Relationship Banker II (Bloomington Whitehall Branch)

Server

Management Trainee - Bloomington

Leasing Consultant Part-Time (The Beverly)

Eligibility Assistant - Front Desk

Pharmaceutical Unarmed Security Officer

Bus Driver

Office Coordinator

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