Sr. Regulatory Manager

Sr. Regulatory Manager at UnitedHealth Group ","FormTypeId":null,"UrlLanguageCode":null,"PreviewType":0,"DateCreated":"2026-03-13T13:45:39.5319907","DateUpdated":"2026-07-13T17:56:15.0506395"}, "site");

Caring. Connecting. Growing together.

With these values to guide us, our people are committed to making a meaningful difference in the lives of those we are honored to serve.

Integrity Compassion Inclusion Relationships Innovation Performance

Sr. Regulatory Manager

Requisition number: 2374059 Job category: Pharmaceutical Research Primary location: Westbury, New York Date posted: 07/13/2026 Overtime status: Exempt Travel: No

Share this job

• Facebook
• X
• LinkedIn
• Email

Optum NY/NJ, is seeking a Regulatory Manager to join our team in Westbury, NY. Optum is a clinician-led care organization that is changing the way clinicians work and live.

As a member of the Optum Care Delivery team, you"ll be an integral part of our vision to make healthcare better for everyone.

At Optum, you"ll have the clinical resources, data and support of a global organization behind you so you can help your patients live healthier lives. We believe you deserve an exceptional career, and will empower you to live your best life at work and at home. Experience the fulfillment of advancing the health of your community with the excitement of contributing new practice ideas and initiatives that could help improve care for millions of patients across the country. Because together, we have the power to make health care better for everyone. Join us and discover how rewarding medicine can be while Caring. Connecting. Growing together.

Primary Responsibilities:

• Study start-up:

• Prepare FDA 1572 with Principal Investigator, sub-Investigator, medical research facility, and clinical laboratory information

• Distribute, collect, and track Financial Disclosure Forms for signatures from Principal Investigator and sub-Investigators

• Submit Regulatory and Laboratory Documents via email and Investigator Portal

• Back-up for distribution and collection of study Delegation of Authority Logs and Training Logs for signatures from Principal Investigator, sub-Investigators, Clinical Research Coordinators, and staff

• Back-up for preparation, submission and obtaining initial approval from Institutional Review Boards

• Participate in Site Initiation Visits

• Prepare and maintain site Study binders; distribute for signatures and collect updated FDA 1572, Financial Disclosure Forms, Delegation of Authority Logs, and Training Logs

• Collect and maintain current CVs, Medical Licenses, and Good Clinical Practice certificates for PI and sub-Investigators

• Prepare regulatory documents such as Protocol Signature Pages and Investigators" Brochures Acknowledgement of Receipts for Principal Investigator"s signature

• Collect and maintain updated local laboratory documents from all affiliated sites

• Communicate with study monitors; supply updated study related documents as requested and answer questions regarding Regulatory documents

• Train on Interactive Web Response Systems for confirming shipment of Investigational Product

• Confirm shipment and inventory Investigational Product

• Prepare Investigational Product for distribution to clinical sites according to Sponsor protocol

• Back-up for study Continuing Review preparation, submission, and obtaining approval from Institutional Review Boards. Submission of changes in Research: change in PI, change in address, name, or the addition/removal of sites

• Back-up for Delegation and Training Logs updating with addition/removal of site staff. Staff notification of updated Protocol Amendments, Informed Consents, Training requirements and Informed Consent signature requirements

• Back-up for IP accountability, preparing Pharmacy Binder, and IP destruction for monitoring visits. Maintaining and recording daily temperatures

• Attend remote monitoring visits and study Close Out Visits

• Prepare, update, and distribute Patient Appointment Lists weekly to Optum Medical Care, PC Clinical Research Coordinators and staff

• Request CT and MRI scans on discs from local radiology departments and upload for Radiologists" review; collect and distribute reports to Principal Investigator, Research Coordinators, and staff

• Prepare, update, and distribute Protocol Flyers to Principal Investigator and sub-Investigators

• Prepare Subject and Informed Consent binders

• Inventory Central Laboratory Kits and Supplies; order as necessary

• Support Clinical Research Coordinators via phone calls, emails, and text messages in the following:

• Assist in the preparation of subject eligibility packets for submission to the Clinical Trial Sponsors

• Distribute Investigational Product to clinical sites for study subjects

• Prepare and distribute central laboratory kits for monthly subject visits

• Process and submit central laboratory specimens according to Sponsor protocol

• Request Archival Tumor Tissue from local laboratories and submit to central laboratories according to Sponsor protocol

• Collect and distribute central laboratory reports to Optum Medical Care, PC Clinical Research Coordinators

• Answer queries from central laboratories

You"ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

• 3+ years of experience in clinical trial regulatory affairs experience within healthcare industry
• Experience preparing, reviewing, and submitting clinical trial applications, amendments, annual reports, and related regulatory documentation
• Experience working on cross-functional clinical development teams
• Demonstrated expertise in clinical trial regulatory activities - study start up, study maintenance and close out
• Solid knowledge of ICH guidelines, GCP guidelines
• Proven ability to manage regulatory timelines and coordinate submissions across multiple studies and regions
• Excellent project management, organizational, and prioritization skills
• Outstanding written and verbal communication skills, including authoring regulatory documents and interacting with health authorities
• Ability to work independently while leading complex regulatory activities

Preferred Qualifications:

• 5+ years of regulatory affairs experience
• Experience with decentralized clinical trials
• Knowledge of oncology clinical trials

Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you"ll find a far-reaching choice of benefits and incentives. The salary for this role will range from $91,700 - $163,700 annually based on full-time employment. We comply with all minimum wage laws as applicable.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.

UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

Apply Internal apply

Bookmark job

Benefits

Our mission of helping people live healthier lives extends to our team members. Learn more about our range of benefits designed to help you live well.

Life

Resources and support to focus on what matters most to you, in every facet of your life.

Emotional

Education, tools and resources to help you reduce and manage stress, build resilience and more.

Physical

Health plans and other coverage to support wellness for you and your loved ones.

Financial

Benefits for today and to help you plan for the future, including your retirement.

Learn more

• Learn more

• Learn more

• Discover our family of businesses See how we're structured to help build a modern, high-performing health system.

Learn more

• Explore our hiring process Learn what to expect when you pursue an opportunity with us.

Learn more

• Benefits that support your well-being Explore opportunities from coast to coast.

Learn more

• Learn more

• Learn more

• Learn more

• Lorem Ipsum Lorem Ipsum is simply dummy text of the printing

Learn more

• Lorem Ipsum Lorem Ipsum is simply dummy text of the printing

Learn more

• Lorem Ipsum Lorem Ipsum is simply dummy text of the printing

Learn more

• How we're transforming care Find out how we're making care smarter and more personalized.

Learn more

• Committed to sustainability Take a look at all the ways we're working for a healthier, more sustainable future.

Learn more

• One team improving health care Here's how we're making the health system more connected and easier to navigate.

Learn more

• Learn more

Load more

Connect with us

• Facebook
• Instagram
• YouTube
• LinkedIn

Do not sell or share my personal information Social responsibility Fraudulent activity Cookie management Site map

Privacy Policy Family & Medical Leave Act (PDF) Equal Employment Law Poster (PDF) SMS Terms & Conditions (PDF) Employee Polygraph Protection Act (PDF) E-Verify Participation Poster (PDF) Pay Transparency Nondiscrimination Provision (PDF) Immigrant and Employee Right to Work Poster (PDF) Health Plan Notices (PDF) County of LA Fair Chance Ordinance (PDF)

2026 UnitedHealth Group. All rights reserved.

UnitedHealth Group is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need special assistance or accommodation for any part of the application process, please call 1-866-566-8715 to be connected to Recruitment Services. Recruitment Services hours of operation are 7 a.m. to 7 p.m. CT, Monday through Friday.

UnitedHealth Group is a registered service mark of UnitedHealth Group, Inc. The UnitedHealth Group name with the dimensional logo, as well as the dimensional logo alone, are both service marks for the UnitedHealth Group, Inc.

UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

×

Fraudulent Activity Notice

We have received recent reports of fraudulent LinkedIn messages and emails alleging or claiming to be sent from UnitedHealth Group, UnitedHealthcare, or Optum Executives.

The fraudulent LinkedIn messages and emails, which do not originate from any Executives LinkedIn account or of UnitedHealth Group's email domains, or those of any of its operating divisions, supposedly conducts an interview via a Zoom meeting, offers a work from home job at Optum, emails an application, sends a fake check by next day delivery through USPS and asks recipients to pay a vendor a large dollar amount. These counterfeit-check cashing schemes exist and use a variety of deceptions to get people to cash these fraudulent checks.

UnitedHealth Group will never request you to pay a vendor or pay a fee of any sort to explore employment opportunities with our company.

If you wish to verify the legitimacy of any email alleging or claiming to have been sent by or on behalf of UnitedHealth Group Executives or Recruiters, please call 1-800-561-0861 between 7 a.m. and 7 p.m. CT, Monday - Friday, for assistance.

×

Our Commitment to Communities

At UnitedHealth Group, we are committed to giving back to the communities where we live and work, across the nation and around the world. Through charitable contributions and volunteering, our people are deeply and personally involved in building healthier communities.

Learn how we are giving back to our communities