Regulatory Affairs Specialist
Singota Solutions
Bloomington, United States | Posted on 04/24/2026 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 Conduct ongoing regulatory surveillance to proactively identify and address upcoming regulatory changes and collaborate with relevant departments to identify and implement necessary changes. Assist in the management of Singota licensing, certifications, and registrations, including but not limited to domestic and foreign agencies, regulatory bodies, and government agencies. Assist in commercial/controlled substance license evaluations of Singota’s supply chain partners to ensure compliance with Drug Supply Chain Security Act (DSCSA) requirements. Support internal compliance with applicable regulatory requirements (e.g., FDA, MHRA, EMA, ICH, etc.) Collaborate with internal departments in addressing regulatory topics and provide guidance as needed. Assist with impact assessments for manufacturing, analytical, facility, and supplier change notifications. Interface with clients during routine project meetings to provide regulatory guidance and support. Coordinate information requests between Client(s) and internal technical functions. Provide support during client and regulatory audits of Singota, ensuring regulatory and quality standards are met. 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. Provide support in preparation and submission of facility Drug Master File (DMF), as well as annual product review(s) (APRs), and annual reporting requirements. Author and review site procedures and specifications to verify adherence to applicable regulations. Design and deliver training sessions and refresher courses to communicate regulatory changes to key stakeholders across the organization. Assist with compilation, formatting, and quality verification of regulatory submissions to ensure accuracy and completeness. Assist in the development and management of audit responses, working collaboratively across functions and ensuring accurate documentation and management of all audit records. Participate in the preparation, evaluation, and modification of client Quality Agreements Provide primary ownership of deviations, CAPAs and change controls as needed. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures. Contribute to the assessment of business opportunities by evaluating potential projects from a regulatory standpoint as part of a cross-functional team. 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. Requirements Skills and Physical Activity Requirements Must possess excellent written and oral skills. Demonstrate a positive attitude and professional presence within the workplace and when interacting with external parties. Must possess strong organizational skills with the ability to manage competing priorities across multiple client programs. Individual must have a strong attention to detail for review and interpretation of quality and regulatory documentation/submissions. Ability to follow established standard operating procedures and established processes; escalating issues appropriately. Education and Work Experience Requirements Bachelor’s degree or equivalent experience – science or regulatory related field preferred. Minimum 3-5 years pharmaceutical experience is required, preferably in a quality/regulatory role. Experience with regulatory submissions/regulatory surveillance is desired. 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 and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment. #J-18808-Ljbffr
- ...Privacy Officer, the Associate Dean for Education and Academic Affairs, the Associate Dean for Hospital Affairs, and the chairs of... ...safety framework across all clinics. Ensure compliance with all regulatory, accreditation, infection control, billing, documentation, and...SuggestedLocal areaImmediate start
- Hoosier Energy seeks a Billing Analyst in Bloomington, IN, to develop monthly billings, manage data collection, and provide technical support. The ideal candidate will have a Bachelor’s degree in a related field or 10 years’ relevant experience, along with 5 years’ experience...Suggested
- A renowned educational institution in Bloomington, Indiana is seeking a project manager for capital planning. The ideal candidate will manage construction processes across multiple regional campuses, ensuring compliance with standards and budgets. Candidates should have...Suggested
- The Chronicle Of Higher Education, Inc. is looking for a Project Manager to oversee the design and construction of capital improvement projects in Indiana. The role requires experienced management of multiple projects, from inception to completion, ensuring quality and ...Suggested
- IU Health is seeking an RN to join its Occupational Health Ambulatory Clinic in Bloomington, IN. This supplemental, outpatient role supports employee health, safety, and wellness through assessments, screenings, injury care, and education. The position offers flexible ...SuggestedFlexible hours
$75k - $90k
Data Support Analyst Department: Information Technology - Data & Reporting Employment Type: Full Time Location: Bloomington, MN Reporting To: Application Support & IT Operations Manager Compensation: $75,000 - $90,000 / year Description We are seeking a Data Support Analyst...Full timeWork at officeRemote work1 day per week- Type: Full Time Qualifications: ~7–10 years of executive leadership in a financial institution (credit union preferred) ~15+ years in financial services with a deep understanding of credit union operations, member expectations, and cooperative principles ~ Strong...Full time
- ...material deliveries and subcontractor activities. Resolve construction issues proactively. Manage inspections, permits, and regulatory requirements. Support project closeout, punch lists, and final documentation. Client Relations Serve as the primary...For subcontractorWork at office
$65k - $70k
Job Description Job Description Company Description The Indiana University Foundation (IUF) is committed to advancing Indiana University by inspiring generosity, strengthening relationships, and supporting opportunities that create lasting impact for students,...Work at officeRemote workMonday to Friday- About Us Jerico Metal Specialties, LLC is a trusted leader in custom metal fabrication and installation. With a strong commitment to precision, innovation, and quality, we deliver specialty metal projects that meet the highest standards in safety and client satisfaction...For subcontractorNight shift
- GENERAL DESCRIPTION The Project Manager is responsible for the overall leadership and management of the project, in a role and reporting structure as designated for the project. The Project Manager is further responsible for the overall administration of the project...Contract workApprenticeshipFor subcontractorLocal area
- Job Title Lead Operations Division Projects Position Summary Lead Operations Division projects to ensure that they are completed within schedule and budget. Plan and designate project resources, prepare budgets, monitor construction progress, and manage communications...Temporary workFor contractorsLocal area
- USA International Harp Competition Bloomington, IN, United States The USA International Harp Competition (USAIHC) is seeking an Executive Director (ED) to lead its operations. This prestigious competition, held every three years at Indiana University Jacobs School of Music...Full timeFor contractorsRemote work
$125k
Objective The Executive Director (ED) serves as the public face of the USA International Harp Competition (USAIHC) and is responsible for administering and executing organizational leadership and operations. To successfully run the USAIHC, the ED must balance high-level...Full timeContract workFor contractorsSeasonal workWork at officeLocal areaRemote workFlexible hoursWeekend workAfternoon shift- Please note that this position is based on our campus in Madison, WI, and requires relocation to the area. We recruit nationally and provide financial relocation assistance. As a Financial Performance Analyst, you'll be working to ensure the financial success of some of...Work experience placementWork at officeRelocationVisa sponsorshipRelocation package
- H&R Block is seeking a seasonal Operations Technical Specialist in Bloomington, Indiana, to ensure the operational readiness of tax offices. The role entails supporting the setup, operations, and closure of seasonal offices while providing technical and logistical assistance...Seasonal work
$17.75 per hour
...the program including delivery of supports, implementation of person-centered plans, health care, advocacy, customer engagement, regulatory compliance and when applicable, oversight of the physical environment. Generally works 8 to 16 flexible hours per week in a supervisory...Hourly payFull timeWork experience placementSeasonal workWork at officeImmediate startAll shiftsFlexible hoursShift workDay shift- Indiana University Bloomington invites applications for a Finance Administration & Budget Analyst in the FAB division. You will deliver financial analysis, reporting, and policy-compliant transaction support for IU and IUF units, with emphasis on accuracy and clear storytelling...
- Incumbent serves as Coordinator for the Community Events Area, with responsibility for the development, planning, implementation, and evaluation of community special events programs. Primary Responsibilities Evaluate community needs to determine and prepare event and program...Part timeLocal areaFlexible hoursAfternoon shift
$15k
Job Description Job Description Description: The Romanoff Group of Companies, headquartered in Columbus, Ohio, with offices in eleven markets covering eight states, are a blend of commercial and residential, electrical, heating & cooling, and plumbing companies primarily...Contract workFor contractorsApprenticeshipLocal areaMonday to FridayFlexible hours$95k - $105k
Salary: $95,000 - $105,000 (based on experience) Requirement: Plumbing License in the service region Position Summary Our client is seeking a results-driven Branch Manager to oversee daily operations at their Bloomington, Indiana location. This leadership role is responsible...Work at officeLocal area- Gopuff is looking for Operations Associates (OAs) to join the operations team. Directly reporting to a Site Leader, OAs play an essential role at Gopuff that requires drive, perseverance, positivity, and enthusiasm for the challenge. You will accomplish a variety of operations...Permanent employmentTemporary workPart timeFlexible hoursShift workNight shiftDay shiftAfternoon shift
$35.57k
Overview The Office of Residential Life (ORL) at Illinois Wesleyan University invites applications for the position of Area Director. ORL is a dynamic department dedicated to providing an exceptional residential experience that fosters student growth, engagement, and success...Full timeLive inWork at officeLocal areaImmediate startVisa sponsorshipWork visa$10k
Looking to grow your career with a organization that cares about you and our goals. At Aspen Dental, we put You first, offering the security and job stability that comes with working with a world-class dental service organization (DSO). Our best-in-class training program...Work at officeRelocation package3 days per week$77.4k - $102.4k
...development strategies, and preparing succession plans for sustained branch growth. Uphold Compliance and Safety: Uphold legal, regulatory, and safety standards across branch operations, fostering an environment prioritizing employee safety and well-being while...Bi-weekly payWeekly payContract workTemporary workWork experience placementWork at officeLocal areaFlexible hours$1,500 per month
Overview Careers close to home and your heart Since our founding in 1997, we've been making long-term care better for our residents and more rewarding for our team members. We're a Fortune Best Places to Work in Aging Services, a certified Great Place to Work, ...Weekly payTemporary workFlexible hours- Managing Director | WealthBridge WealthBridge Financial Group is seeking a proven financial advisor for a strategic Managing Director role. This role is ideal for an experienced advisor who has successfully built a personal practice and is now ready to take on a leadership...Visa sponsorship
- Company Description The USA International Harp Competition (USAIHC) is a triennial performance competition held at Indiana University Jacobs School of Music in Bloomington, Indiana. Founded in 1989 by Susann McDonald, world‑renowned harpist and pedagogue, the USAIHC is ...Full timeFor contractorsWork at officeRemote work
- Our values start with our people, join a team that values you! Bring your talents to Ross, our leading off-price retail chain with over 2,200 stores, and a strong track record of success and growth. Our focus has always been bringing our customers a constant stream of...Work at officeLocal areaImmediate startShift workWeekend workAfternoon shift
$600 per month
We are a fast-growing financial services organization focused on helping families protect what matters most. We prioritize fast pay, low startup costs, and hands‑on training, so you can focus on learning the role and building income from day one. What You’ll Be Doing Client...Full timePart timeRemote workFlexible hours2 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
- regulatory contract Bloomington, IN
- regulatory Bloomington, IN
- housing compliance Bloomington, IN
- customs compliance Bloomington, IN
- compliance Bloomington, IN
- corporate compliance Bloomington, IN
- clinical compliance Bloomington, IN
- regulatory affairs Bloomington, IN
- health compliance Bloomington, IN
- regulatory affairs assistant Bloomington, IN




