Director of Regulatory Reporting Job at Robert Half (Wilmington)

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

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

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

Associate Director

Location

United States , New York

Salary:

150000.00 - 200000.00 USD / Year

Arrow Search Partners

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
3-7 years of experience in a compliance role
J.D. required
Understanding of federal securities law and regulations strongly preferred
Experience with private fund marketing or distribution compliance a plus
Experience using compliance software/programs that support monitoring, reporting, and risk assessment activities
Ability to interpret legal and business terms and grasp concepts quickly

Job Responsibility

Coordinate across the firm on fund and managed account compliance and regulatory matters including SEC and CFTC registrations, ERISA, and federal, state and international securities laws
Review marketing materials, due diligence responses, investor communications and other fundraising and reporting related materials across various investment strategies
Coordinate and prepare U.S. and foreign regulatory reports and filings
Assist with forensic testing for annual compliance review
Assist with the compliance monitoring program including testing of investment guidelines and employee compliance requirements
Support selected firm-wide legal and compliance initiatives

Medical Director, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Devel...

Location

United States , Waltham; San Diego

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently
self-starter attitude
MD or equivalent is required

Job Responsibility

Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators

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

Senior Director Public Health

The Senior Director, Public Health provides scientific and strategic leadership ...

Location

United States , Washington, DC

Salary:

150000.00 - 165000.00 USD / Year

American Cleaning Institute

Expiration Date

Until further notice

Requirements

Master’s degree required or Doctorate preferred, in public health, or a related field
Minimum 5 years of experience in scientific research management, regulatory science, or related public health programs
experience with FDA-regulated products strongly preferred
Demonstrated experience managing multi-stakeholder research programs or clinical studies under FDA frameworks
Comprehensive understanding of FDA rules and regulations, topical antiseptic safety and efficacy requirements, and relevant regulatory guidance
Excellent scientific writing and communication skills, including experience preparing manuscripts, white papers, and regulatory submissions
Exceptional oral and written communication skills
Ability to interact productively with both internal and external stakeholders, including non-scientific audiences
Proven ability to manage contractors, academic partners, and collaborations on scientific projects
Ability to work within a team environment as well as independently

Job Responsibility

Lead and oversee ACI’s Topical Antiseptics Program, including clinical and technical research supporting the FDA OTC Monographs and related scientific priorities
Keep abreast of emerging science and regulatory policies, monitor technical literature, and write and review technical reports, white papers, and publications for peer-reviewed scientific journals
Direct design, execution, and analysis of studies assessing product safety, efficacy, and antimicrobial benefits. Ensure compliance with regulatory and scientific standards
Serve as the primary scientific liaison to FDA and other regulatory bodies on antiseptic-related topics
interpret and communicate evolving regulatory expectations to ACI leadership and members
Coordinate and facilitate scientific work groups, technical committees, and member coalitions advancing antiseptic science
Prepare status/progress reports for presentation to ACI’s leadership and members
Develop and administer program budgets and deliverables
oversee contracts, research partnerships and consultant engagement
Develop and deliver scientific messaging for external stakeholders such as at scientific and technical conferences and meetings, and audiences for ACI technical communications

Director - FRTB Market Risk RWA Calculation and Analysis

The position leads the Calculation and Analysis of FRTB Market Risk RWA across m...

Location

United States , New York

Salary:

170000.00 - 300000.00 USD / Year

Citi

Expiration Date

Until further notice

Requirements

10+ years of experience in Market Risk and RWA calculations
Deep expertise in FRTB implementation for a large, global Bank
Strong familiarity with FRTB rules in more than one jurisdictions
Subject matter expertise in trading book products, strategies, and risk management across multiple asset classes
Strong background in working with Technology on implementation of large, complex programs involving Front office Risk Management systems and Market/Reference data
Familiar with FRTB implementation challenges, advocacy proposals, and state-of-play across the Street
Experience in supporting Regulatory exams with US/UK/EU banking supervisors, and experience in working with Internal Audit
Hands-on data analytics experience using Python/Tableau/SQL
Working knowledge of Market Risk models and methodologies
5+ years managerial experience

Job Responsibility

Own production of FRTB Market Risk RWA results, including analysis of drivers, for both Citigroup and selected Legal Entities in EMEA and Asia
Manage a large team spread across NY, Warsaw, and Mumbai, including managing other people managers
Partner with other key stakeholders to ensure Citi's compliance with FRTB Rules and Regulatory expectations
Responsible for working with Technology to drive FRTB implementation and remediation
Closely coordinate with Front Office and Market Risk to improve the quality of FRTB results
Serve as key contributor for FRTB related Regulatory Exams, Internal Audit, and Second Line of Defense Reviews
Work with Regulatory Policy teams on interpretive items, and on ensuring governance of implementation assumptions
Contribute to FRTB advocacy efforts and impact studies, both bilaterally and representing Citi in industry FRTB forums

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages including vacation, sick leave, and holidays

Fulltime

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Director of Regulatory Reporting

Job Description

Job Responsibility

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