Regulatory Affairs Specialist

Singota Solutions•Bloomington, IN

1d•Remote

About The Position

The Regulatory Affairs Specialist supports and executes Singota’s regulatory affairs and compliance programs, including day-to-day regulatory operations and regulatory guidance for clients. The role provides CMC regulatory support, prepares and manages regulatory documentation, and coordinates with internal and external technical teams and stakeholders to support compliance with applicable regulatory standards and guidance. It also supports implementation and maintenance of procedures that keep the regulatory program effective and efficient. The position is remote, with routine onsite presence as needed for audits and other business requirements.

Requirements

Excellent written and oral communication skills.
Positive attitude and professional presence in the workplace and when interacting with external parties.
Strong organizational skills and ability to manage competing priorities across multiple client programs.
Strong attention to detail when reviewing and interpreting quality and regulatory documentation and submissions.
Ability to follow established SOPs and processes and escalate issues appropriately.
Bachelor’s degree or equivalent experience; a science or regulatory-related field is preferred.
Minimum 3–5 years of pharmaceutical experience; quality or regulatory experience is preferred.
Proficiency in Microsoft Office.

Nice To Haves

Experience with regulatory submissions and regulatory surveillance is desired.
Familiarity with document management systems and eQMS platforms is desired.

Responsibilities

Conduct ongoing regulatory surveillance to identify upcoming regulatory changes and collaborate with relevant departments to implement necessary changes.
Assist in managing domestic and foreign licenses, certifications, and registrations with regulatory and government agencies.
Assist with commercial and controlled-substance license evaluations of supply-chain partners for compliance with DSCSA requirements.
Support internal compliance with applicable requirements, including FDA, MHRA, EMA, and ICH requirements.
Collaborate with internal departments on regulatory topics and provide guidance as needed.
Assist with impact assessments for manufacturing, analytical, facility, and supplier change notifications.
Provide regulatory guidance and support to clients during routine project meetings.
Coordinate information requests between clients and internal technical functions.
Support client and regulatory audits of Singota.
Support preparation of client regulatory submission documentation, including INDs, NDAs, and BLAs, as applicable.
Support preparation and submission of facility DMFs, annual product reviews, and annual reporting requirements.
Author and review site procedures and specifications to verify adherence to applicable regulations.
Design and deliver training and refresher courses communicating regulatory changes to stakeholders.
Assist with compilation, formatting, and quality verification of regulatory submissions.
Assist in developing and managing audit responses and maintaining accurate audit documentation and records.
Participate in preparing, evaluating, and modifying client Quality Agreements.
Own deviations, CAPAs, and change controls as needed.
Comply with quality and safety management systems, including documentation, training, system use, SOPs, processes, and procedures.
Contribute regulatory evaluations of potential projects as part of a cross-functional business-opportunity assessment.
Perform general support tasks inside and outside the department to meet business needs.