Governance, risk and compliance

SmartSuite for the Regulatory Affairs Manager

The Regulatory Affairs Manager manages the organization's relationship with its regulators: licenses and registrations, filings and submissions, inquiries and examinations, and the commitments made in response. They keep the regulatory calendar and make sure every deadline is met with evidence.

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What you own

The Regulatory Affairs Manager manages the organization's relationship with its regulators: licenses and registrations, filings and submissions, inquiries and examinations, and the commitments made in response.

  • Maintain the register of regulators, licenses and registrations
  • Manage the regulatory filing calendar and submissions
  • Coordinate responses to regulatory inquiries and examinations
  • Track commitments made to regulators through to completion
  • Monitor regulatory developments relevant to the organization
  • Brief leadership on regulatory interactions and risks

At a glance

The GRC processes this role owns, touches and depends on.

Owns

accountable for the process

compliance

Touches

contributes or approves

issues-actions, reporting, policy

Depends on

consumes its output

risk, audit

How the GRC processes connect

Three lines of defense set the frame; the chain shows where each process hands off to the next. Colors follow the role: navy is owned, blue is touched, gray is depended on.

Reporting lines

Who this role reports to, who reports to them, and the peers they work with most.

Reports to

Chief Compliance Officer

Chief Compliance Officer

See the role

Direct reports

Works closely with

Regulatory Change Manager

Regulatory Change Manager

See the role
General Counsel

General Counsel

See the role
Compliance Director

Compliance Director

See the role
Compliance Officer

Compliance Officer

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How SmartSuite supports this role

Lead

Compliance management. Holds the regulatory calendar with filings, licenses and renewal dates, with reminders and evidence attached to each obligation.

Issues and actions. Manages regulatory inquiries and examination requests as tracked cases with owners, deadlines and response documents.

Reporting. Reports regulatory interactions, open commitments and upcoming deadlines to leadership.

Products this role uses most

Regulatory Inquiries
Manage regulatory requests and exams with response workflows, evidence on each inquiry record, and visibility into status and deadlines.
Regulatory Change Management
Track and implement regulatory changes with impact assessments, obligation owners, implementation workflows, and visibility into compliance readiness.
Compliance Assessments & Testing
Manage assessment campaigns and testing schedules with a reusable question library, automated workflows, and one place for evidence collection.
Entity & Corporate Governance Management
Manage legal entities, governance, and compliance with a centralized platform for corporate structure and oversight.

Industry reference

The role is defined by whoever licenses the organization. Banks hold charters from the OCC, state regulators or the FCA/PRA and file under their rulebooks; investment advisers file Form ADV with the SEC; insurers are licensed state by state under NAIC-based law. ISO 37301:2021 covers the engagement and commitment-tracking practice.

Healthcare organizations manage CMS certification, state licensure and accreditation surveys; life-sciences firms follow the RAPS body of knowledge for FDA and EMA submissions. Public bodies answer to inspectors general and legislative audit; technology companies increasingly manage data protection authorities, telecoms regulators and the EU's digital rulebook.

Related roles

Chief Compliance Officer

Chief Compliance Officer

See the role

Frequently asked questions

What does a Regulatory Affairs Manager own?

The Regulatory Affairs Manager owns the organization's relationship with its regulators: the register of regulators, licenses and registrations, the filing calendar and submissions, the responses to inquiries and examinations, and the commitments made in response, tracked through to completion. They monitor regulatory developments relevant to the organization and brief leadership on regulatory interactions and risks. The measure of the role is that every deadline is met with evidence and every promise to a regulator is kept.

How does SmartSuite help a Regulatory Affairs Manager run the regulatory calendar?

SmartSuite holds the regulatory calendar with filings, licenses and renewal dates, with reminders and evidence attached to each obligation, so a license renewal or a periodic filing arrives as a reminder with last year's submission beside it. Entity & Corporate Governance Management holds the entities and registrations the obligations belong to, which matters for groups licensed in several jurisdictions. The Regulatory Affairs Manager sees what is due, for which entity, to which regulator, and what evidence is already in hand.

How are regulatory inquiries and examinations managed?

Regulatory Inquiries manages regulatory inquiries and examination requests as tracked cases with owners, deadlines and response documents, so each request from a regulator becomes a case with the person responsible for the answer, the date it is due and the documents sent. The Regulatory Affairs Manager coordinates the response across functions from that case and the General Counsel can review it before it goes. After the examination, the commitments made are tracked from the same record.

How does this role keep up with regulatory developments?

Regulatory developments are monitored with the Regulatory Change Manager, and Regulatory Change Management is where a new or amended rule is logged so that the obligation it creates can be added to the calendar rather than noted in a meeting and forgotten. The Regulatory Affairs Manager's part is the regulator's side of the change: a new filing, a changed license condition or an examination theme. Because the calendar and the change record sit in the same system, a development becomes a dated obligation with an owner.

How does a Regulatory Affairs Manager brief the Chief Compliance Officer?

SmartSuite reports regulatory interactions, open commitments and upcoming deadlines to leadership, so the briefing to the Chief Compliance Officer is drawn from the calendar and the inquiry cases as they stand. Open commitments to regulators, examinations in progress and filings due in the coming period appear together, and the Compliance Director and Compliance Officer see the same view for their own areas. When the board asks what was promised to a regulator and whether it was delivered, the record answers.

What does it take to get the regulatory calendar into SmartSuite?

The list of regulators, licenses and registrations by entity, the recurring filings with their due dates and the open inquiries and commitments; with those, reminders and the leadership view work from the first cycle. Evidence from past submissions is attached as each obligation next falls due. Most Regulatory Affairs Managers start with the calendar because missed deadlines are the risk, then move inquiries into tracked cases at the next examination. Compliance Assessments & Testing links the calendar to the wider compliance program.

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