Senior Associate, NA Regulatory FIO

Haleon

Augusta (GA)

Hybrid

USD 79,000 - 109,000

Full time

6 days ago
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Benefits offered by this job

401(k) plan
Tuition reimbursement
6 months paid parental leave
Healthcare coverage for you and your/家

Job summary

Haleon is seeking a Senior Associate for NA Regulatory FIO in Richmond, VA. The role focuses on creating and maintaining Formulation and Labeling Forms (FLFs) across OTC, dietary supplements, cosmetics, and medical devices, collaborating with Product Development, Regulatory, and QA to ensure compliant documentation throughout the lifecycle.

You will manage regulatory CMC documentation related to composition, support change management, and help ensure GDP and cGMP compliance while navigating

Qualifications

  • Educational background in chemistry, pharmacy, biology or related science.
  • 0–5 years of experience in a technical writing, quality/regulatory, or product development role.
  • Uses technical writing skills in MS Word, Excel, PowerPoint.
  • Understands change management and CAPA processes.
  • Soft skills with negotiations, collaboration, and influence of stakeholders to drive compliance and meet timelines.
  • Knowledge of applicable GxP and regulatory requirements.
  • Experience navigating organizational complexity with multiple teams.

Responsibilities

  • Collaborates with stakeholders and maintains formula composition documentation for product lifecycle from development to launch.
  • Supports review and approval of formula/ingredient documentation for accuracy and traceability.
  • Develops knowledge of regulations related to product formula and labeling for FLF.
  • Engages with project teams as key contact for product composition and labeling to maximize efficiency.
  • Manages documentation in systems like Veeva Quality and Veeva RIMS.

Skills

Technical Writing
Regulatory Knowledge
GxP Knowledge
Collaboration
Change Management
CAPA
Stakeholder Influence

Education

Bachelor of Science in Chemistry, Pharmacy, Biology or Related Science

Tools

MS Word
Excel
PowerPoint

Job description

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

About the role

The Senior Associate, NA Regulatory FIO is responsible for the creation and maintenance of Formulation and Labeling Forms (FLF), supporting NA Product Development and Regulatory functions, as part of the Formulation Ingredient Operations (FIO) team. This role authors and maintains formula documentation throughout product lifecycle, including product development transfer, and commercialization of formulations for OTC Drugs, Dietary Supplements, Cosmetics, and Medical Devices (formulated), liaising between Product Development or Site Technology/Quality and Regulatory Labeling.

This role plays a critical part in ensuring the smooth operation of FIO processes by maintaining high-quality data, supporting regulatory documentation, and enabling effective collaboration across functions, ultimately contributing to compliant product lifecycle management and successful regulatory outcomes.

Key responsibilities
  • Collaborates with stakeholders and maintains formula composition documentation, as Formulation and Labeling Forms (FLFs) supporting the product lifecycle throughout development, product transfer, and launch; and commercial formulations via change management.
  • Supports review and approval of formula/ingredient supporting documentation to ensure accuracy, completeness, and traceability of information provided.
  • Develops knowledge of regulations related to product formula and ingredient labelling with respect to the FLF.
  • Engages with project teams as key point of contact for aspects related to product composition and/or labelling, driving cross-function collaboration with Product Development and Regulatory, to maximize efficiency of the supporting documentation and authoring processes.
  • Responsible for management of documentation and data in relevant documentation systems (e.g. Veeva Quality and Veeva RIMS) and databases.
  • Develops understanding of Quality and Regulatory requirements to assist colleagues and stakeholders in formulation management activities.
  • Support authoring of Regulatory CMC documentation related to composition, as needed.
  • May manage internal databases.
  • Comply with relevant Regulatory SOPs and systems. Follows Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
Qualifications and Skills
Essential
  • Educational Background: Bachelor of Science Degree in Chemistry, Pharmacy, Biology or Related Science
  • 0-5 yrs of experience in a Technical Writing, Quality/Regulatory, or Product Development role
  • Utilizes technical writing skills in applicable software (MS Word, Excel, PowerPoint)
  • Understands change management and CAPA processes
  • Soft skills with negotiations, collaboration, and influence of stakeholders to drive compliance and meet project timelines
  • Knowledge of applicable GxP and Regulatory requirements
  • Demonstrated experience in navigating through organizational complexity and collaborating simultaneously with multiple teams.
Preferred
  • Attention to Detail - Be comfortable working in a faced-paced, dynamic environment maintaining a strong attention to detail.
  • Problem Solving - Demonstrates ability to take initiative, think and work independently, problem-solve, work effectively in teams, and multitask.
  • Adaptability and Flexibility – Ability to manage multiple tasks, or switch task as needed, keeping focus and delivering on project milestones.
Location

This role is located in Richmond, VA and is hybrid, requiring 3 days per week onsite.

The salary range for this role is:

$78,963 - 108,574 plus an 8% on target bonus.

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

2026-11-03

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to HR.AmericasSC-CS@haleon.com. Please include the following in your email:

Use subject line: ‘Haleon Careers: Job Accommodation Request’

Your Name and contact information

Requisition ID and Job Title you are interested in

Location of Requisition (city/state or province/country)

Description of specific accommodation you are requesting

Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.

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