The Role
Support regulatory operations for pharmaceutical clients: conduct regulatory surveillance, manage licenses and controlled-substance compliance, assist with CMC and submission documentation (IND/NDA/BLA/DMF), coordinate audits and audit responses, author procedures, support change notifications, and provide regulatory guidance to internal teams and clients to ensure compliance with FDA, EMA, MHRA, ICH and other requirements.
Summary Generated by Built In
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.
Requirements
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
Skills Required
- Bachelor's degree or equivalent
- Minimum 3-5 years pharmaceutical experience in quality/regulatory
- Proficiency in Microsoft Office
- Strong written and oral communication skills
- Strong organizational skills and ability to manage competing priorities
- High attention to detail for review and interpretation of regulatory documentation
- Ability to follow SOPs and established processes, escalate issues appropriately
- Experience with regulatory submissions and regulatory surveillance
- Familiarity with document management systems and eQMS platforms
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The Company
What We Do
Singota Solutions is a cGMP-compliant and FDA-registered Contract Development and Manufacturing Organization (CDMO) based in Bloomington, Indiana. The company helps clients in the pharmaceutical, animal health, and biotechnology industries accelerate drug development. They specialize in aseptic manufacturing, formulation development, supply chain management, and analytical testing, using robotic technology to produce high-quality injectable medicines in vials, syringes, and cartridges.
