Director of Regulatory Reporting Job at Robert Half (Wilmington)

Audit Director – U.S. Regulatory Reporting Transaction Testing

The Audit Director is a senior level management position responsible for contrib...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

BA/BS or equivalent
Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus
Statistical, Computer Science or Computer Engineering qualifications will be an advantage
15+ years of experience in a related role
Understanding of industry best practices and regulatory expectations for Data management (e.g. BCBS 239)
Knowledge of data quality software including Big Data (e.g. Paxata, Hadoop) will be an advantage
Detailed knowledge of substantive testing methodologies designed to assess the material accuracy of key reports, including data tracing and transaction vouching
Demonstrated experience in managing teams and managing integrated internal audit and assurance delivery within a matrix reporting environment

Job Responsibility

Development and completion (and ongoing update) of an effective audit strategy and plan (including budgets) that provides thorough, risk based substantive coverage of the data utilized in certain U.S. Regulatory Reports
Working closely with Product and Function Chief Auditors to ensure delivery of a plan of work that provides assurance for the accuracy of these reports
Interacting with U.S. regulators to provide updates and briefings on audit perspectives of the quality of the data utilized in report production
Contributes to strategic direction of Citi’s Internal Audit (IA) function in the establishment of reporting methodologies, organizational design and effective positioning of the function to ensure provision of independent assurance
Uses excellent communication, leadership and strong management skills to influence a wide range of internal audiences including respective product or, function, executive management partners and external audiences including regulators and external auditors
Responsible for the delivery of a high quality, value-added regulatory-required audits on time and to specification
Ensures the delivery of an audit reports that is complete, insightful, timely, error free and concise
Ensures timely delivery of high-quality comprehensive regulatory and internal audit issue validation, and, where determined appropriate, issue validation on other remediation actions, including issues arising from the external auditors, consultants and other parties
Contributes towards the delivery of high impact reports of IA's contributions to executive management, regulators, and Citigroup and Citibank boards' sub-committees, developing trend analyses and thematic reporting
Manages multiple teams of professionals

Fulltime

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Senior Audit Manager

The Senior Audit Manager is a senior level management position responsible for m...

Location

Costa Rica , Heredia

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

10+ years of experience in a related role
Related certifications (CPA, ACA, CFA, CIA, CISA or similar) preferred
Demonstrated successful experience in business, functional and people management
Proven ability to execute concurrently on a portfolio of high quality deliverables according to strict timetables
Demonstrated ability to implement continuous improvement and innovation in audit tools and techniques
Consistently demonstrates clear and concise written and verbal communication
Demonstrated ability to remain unbiased in a diverse working environment
Effective negotiation skills
Advanced English level
Advanced knowledge with US regulatory reporting, including financial-statement based reporting and/or regulatory capital reporting

Job Responsibility

Manage a team of Internal Audit professionals, recruit staff, lead professional development, build effective teams and manage a budget
Deliver audit reports, Internal Audit and Regulatory issue validation and business monitoring and governance committee reports
Lead reviews for all types of reviews, including the most complex, and review and approve Business Monitoring Quarterly Summaries
Participate in major business initiatives and pro-actively advise and assist the business on change initiatives
Implement integrated auditing concepts and technology, and follow trends in the Audit field and adapt them for the Audit function
Identify solutions for a variety of complex and unique control issues, utilizing complex judgement and sophisticated analytical thought
Analyze report findings, and recommend interventions where needed, proposing creative and pragmatic solutions to risk and control issues
Partner with Directors and Managing Directors to develop approaches for addressing broader corporate emerging issues
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency, as well as effectively supervise the activity of others and create accountability with those who fail to maintain these standards

What we offer

Global Benefits
We bring the best to our people. We put our employees first and provide the best-in-class benefits they need to be well, live well and save well

Fulltime

Interim Finance Director

Interim Finance Director – Global FX Payments Business (UK)- 3-6 Month Contract-...

Location

United Kingdom , London

Salary:

Not provided

IN2 Consult

Expiration Date

Until further notice

Requirements

Significant experience in the payments industry
ideally with exposure to FX payments and derivatives
proven regulatory reporting experience, including oversight of CAS / client assets and regulatory submissions
previous experience as a Finance Director or senior finance leader in a regulated environment
ACA, ACCA or CIMA Qualified
demonstrated ability to deliver in fast-paced, interim assignments with minimal ramp-up time
experience managing a small team and working closely with executive leadership and the board
immediate or near-immediate availability is highly desirable

Job Responsibility

Lead the finance function with full accountability for financial reporting, regulatory submissions, and compliance
oversee client assets, safeguarding, and CASS/CAS obligations where relevant
provide executive-level financial guidance to the CEO and board, including scenario modelling, forecasting, and decision support
manage and develop a small finance team, ensuring operational excellence and timely delivery of financial outputs
drive process improvements, system implementations, and efficiency initiatives across finance operations
ensure regulatory licence obligations (e.g., MIE, EMI) are met, liaising with auditors and regulators as needed

Director of Investment Operations

Join a leading firm specializing in responsible, sustainable investing. The firm...

Location

United States , San Francisco

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

15+ years in investment servicing, finance, or fund accounting
10+ years of team management experience
Deep knowledge of mutual funds, ETFs, and separately managed accounts
Strong understanding of financial reporting, GAAP, and regulatory compliance
Advanced education (MBA or relevant designation) preferred

Job Responsibility

Oversee investment product operations, including reporting, accounting, fund expenses, performance calculations, trade settlement, and SEC disclosures
Serve as the primary liaison for audits, SOX testing, and compliance reviews
Manage relationships with external administrators, custodian banks, and third-party providers
Prepare investor communications and ensure timely month-end reporting
Contribute to strategic planning, new product launches, and special projects
Assist with board-related matters as Assistant Treasurer for the Mutual Funds Board

What we offer

competitive compensation
comprehensive benefits
100% healthcare coverage for employees and families
commuter subsidies

Fulltime

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Audit Director

The Audit Director is a senior level management position responsible for contrib...

Location

Canada , Mississauga

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

15+ years of experience in a related role
Compliance Risk Management experience in second or third line of defense is preferred
Demonstrated success in business, functional and people management
Consistently demonstrates clear and concise written and verbal communication
Demonstrated ability to remain unbiased in a diverse working environment
Effective negotiation skills

Job Responsibility

Leads a global team of auditors to provide timely and complete assurance over the US Regulatory Issue Validations
Responsible for planning of audit coverage and delivery of high quality, value-added Regulatory Issue Validations in accordance with audit methodology
Leads validations owned by ICRM and coordinates models subject matter expertise for all other audit teams
Proactively manages IA’s relationship with multiple internal and external stakeholders, including senior risk and business executives, and government regulators
Uses communication and leadership skills to influence a wide range of senior internal and external audiences
provides impactful, valuable and ongoing IA input through active interactions with stakeholders and formal participation at key committees and management initiatives
Possesses, through direct hands-on experience, a strong understanding of Audit and Compliance
maintains an understanding of key relevant regulations, current business practices and industry trends
Supports and endorses the Quality Assurance (QA) function of IA, and resolve issues found by QA, improving audit processes and coverage
Ensures the adoption of Citigroup and Citibank Audit Committee Charters and the IA Charter, and engages in internal/external negotiations

Fulltime

Director of Regulatory Reporting

Robert Half

Location:
United States , Wilmington

Category:
Finance

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 27, 2025

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