regulatory Jobs in Boston, MA

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Sr. Manager, Regulatory Operations

Apex Systems

Waltham, Massachusetts, USA

Full-time

Job#: 2067675 Job Description: Sr. Manager, Regulatory Operations 2067675 Location: Waltham, MA (Hybrid) Focus: Small Molecule Job Overview: The Senior Manager for Regulatory Operations will handle regulatory submissions, liaise with global authorities, and strategize RNA-focused clinical development. Primary Job Responsibilities: Manage regulatory submissions, ensuring accurate preparation and publishing to global agencies.Assist in drafting and quality-checking regulatory materials and tem

Solution Architect with Pharma & Regulatory Experience

The Dignify Solutions, LLC

Remote or Raritan, New Jersey, USA

Contract, Third Party

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r

Regulatory affairs - CMC Manager

Sureminds Solutions

Remote

Third Party, Contract

Job Title: Regulatory affairs - CMC Manager Location: Remote Duration : 11 Months Interview Mode : Video PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Job Description : Responsibilities will include, but are not limited to, the following: Participate in the development of the CMC regulatory strategy for post-approval small

Senior Model Risk Management & Governance Specialist - Financial Models, AI/ML, AML, Scorecards, and Regulatory Compliance

Ohm Systems, Inc

Remote

Contract

Model Risk Management requirements: Responsible for managing the execution of validation activities for financial models, acquisition and portfolio management scorecards, AML models and anti-fraud tools in accordance with the governance framework, policies and procedures, and provide recommendations for continuous model enhancements across the enterprise. Actively manages and escalates risk and customer-impacting issues within the day-to-day role to management. Manages independent model validati

VP, Data Analytics Lead Analyst (Financial regulatory reporting)

Citi

Remote or Irving, Texas, USA

Full-time

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Our core activities are safeguarding assets, lending money, making payments and accessing the capital markets on behalf of our clients. Citi's Mission and Value Proposition explain what we do and Strategy explain how we do it. Our mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and ec

Senior Model Risk Management & Validation Specialist - Financial Models, AI/ML, AML, Credit Risk, and Regulatory Compliance

Ohm Systems, Inc

Remote

Contract

Model Risk Management requirements: Responsible for managing the execution of validation activities for financial models, acquisition and portfolio management scorecards, AML models and anti-fraud tools in accordance with the governance framework, policies and procedures, and provide recommendations for continuous model enhancements across the enterprise. Actively manages and escalates risk and customer-impacting issues within the day-to-day role to management. Manages independent model validati

Regulatory affairs - CMC Manager

American IT Systems

Remote

Contract

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.Prepare a

CMC Regulatory Technical Writer II

SGS Consulting

Remote

Contract

Title: CMC Regulatory Technical Writer II Location: 100% Remote Job Duration: 12 months (Contract, possibilities of extension) Description: The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in client's lifecycle management (LCM) programs. They collaborate directly with client's global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU and rest of world (ROW) dossiers (e.g

AWS Solution Architect, Regulatory Strategy : : and USC

Srimatrix Inc.

Remote

Contract, Third Party

Role: Solution Architect, Regulatory Strategy location: Remote (EST Hours) **MUST HAVE Pharmaceutical Regulatory experience **AWS-Certified Solutions Architect certification required Education: BA/BS degree in a technical, engineering or scientific fieldAWS-Certified Solutions Architect certification requiredAWS Well-Architected Framework certification desirableAWS Certified Machine Learning Specialty certification desirable Experience and Skills: Required: Understanding of Pharmaceutical Regul

Data Regulatory Execution Lead Analyst - VP - New York (Hybrid)

Citi

Remote or New York, New York, USA

Full-time

About the team: As part of the Risk Data Transformation team of the Enterprise Data Office, you will be part of a team responsible to: Establish, maintain, and communicate the Risk Data transformation strategyDrive the remediation and adoption of consistent data management standards and capabilities to support the Enterprise Risk Management Framework across the enterprise and relevant businesses / functions / regions. About the role: The Citi Data Governance Policy (CDGP) provides a framework

VP, Data Analytics Lead Analyst (Financial regulatory reporting) C13

Citi

Remote or Jacksonville, Florida, USA

Full-time

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Our core activities are safeguarding assets, lending money, making payments and accessing the capital markets on behalf of our clients. Citi's Mission and Value Proposition explain what we do and Strategy explain how we do it. Our mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and ec

SVP, Tech & Cyber Risk - Regulatory & Governance Management Officer - C14 (Hybrid)

Citi

Remote or New York, New York, USA

Full-time

Individuals in Operational Risk establish and manage operational risk policies, propose strategies, and governance processes designed to minimize losses from inadequate controls, fraud, and potential bankruptcy. This includes supervision over technology operational risk, cyber risk, and fraud risk. These individuals are also responsible for the development of tools and infrastructure that support fraud monitoring and prevention, using advanced analytical and statistical skills to identify policy

USA - Regulatory Affairs Associate III

Robert Half

Remote or Chapel Hill, North Carolina, USA

Contract

Description We are seeking a Regulatory Affairs Associate to join our team. This opportunity offers a long term contract employment with the possibility to work fully remotely or in hybrid mode from Chapel Hill, North Carolina. As a Regulatory Affairs Associate , you will play a key role in coordinating and preparing regulatory submissions, reviewing technical data, and managing regulatory documentation. Responsibilities: Coordinate the preparation of documents and packages for regulatory subm

Senior Regulatory Affairs SME

LMI Government Consulting (Logistics Management In

Remote

Contract

Overview LMI is seeking a Senior Regulatory Affairs SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates w

Remote : SAP Finance4U Regulatory Reporting

SoftPath Technologies LLC

US

Third Party, Contract

Hi, Greetings For The Day, I'm Sushmitha from SoftPath Technologies LLC and works in a Recruitment. We have a position for SAP Finance4U Regulatory Reporting @ Remote with our client and your profiles matches to requirement. Can you please check below JD and if you are interested then please share your updated resume to Skill: SAP Finance4U Regulatory Reporting Location : Remote With Occasional Travel Duration : Long Term Exp: 10-12+yrs Job Description / Responsibilities: Consulting Services:

Solutions Architect (Regulatory Strategies)

Enterprise Engineering

Remote

Contract, Third Party

Solution Architect, Regulatory Strategy Remote (EST Hours) Contract Opportunity **MUST HAVE Pharmaceutical Regulatory experience **AWS-Certified Solutions Architect certification required Client is seeking an experienced Solution Architect to support Regulatory Strategy projects. The Regulatory Strategy Product Group delivers solutions which drive process orchestration, intelligent automation, advanced analytics and predictive modelling for Global Regulatory Affairs in Innovative Medicine. The

Technical Business Analyst (AML + Trade surveillance)

Xoriant Corporation

Boston, Massachusetts, USA

Contract

Needs experience in Trade Surveillance, Compliance, Fraud detection, Analyze Trade Activities/ Trade Data, detect suspicious activity, KYC/AML, Implementing surveillance System, Regulatory best practices. Need experience in SQL

Product Security Engineer

Talent Groups

Beverly, Massachusetts, USA

Third Party, Contract

Key Skills: Security risk management, regulatory standards, Pre-market product development activities, Medical devices, FDA Job Description: 5+ years industry experience in Information Security.Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR).Experience with security risk management techniques.Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a t

Product Security Engineer

Sharpedge Solutions

Danvers, Massachusetts, USA

Full-time

5+ years industry experience in Information SecurityWorking knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR)Experience with security risk management techniquesDemonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlinesCommitted to working with a sense of urgency and embracing new challengesExperience working i

Product Security Engineer

Vankay Systems

Danvers, Massachusetts, USA

Contract

Role: Product Security Engineer Hiring Mode: Contract (TP) Location: Danvers, MA-01923 [On-site] Skills Matrix Skill Last Used Experience in Years/month Rating (10 points) 1 = newbie 10 = expert Hands on Exp. Yes/No Security risk management techniques Regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR) Pre-market product development activities Medical devices FDA Job Description: 5+ years industry experience in Information Security.Wor