Senior Associate, NA Regulatory FIO

Haleon plc.

Richmond (VA)

Hybrid

USD 79.000 - 109.000

Vollzeit

Vor 7 Tagen
Sei unter den ersten Bewerbenden
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Benefits dieser Stelle

401(k) plan
Tuition reimbursement
Parental leave
Health insurance

Zusammenfassung

Haleon is seeking a Senior Associate, NA Regulatory FIO in Richmond, VA, to create and maintain Formulation and Labeling Forms (FLFs) for OTC, dietary supplements, cosmetics, and medical devices. You will liaise with Product Development, Site Technology, Quality, and Regulatory Labeling to ensure compliant lifecycle documentation.

The role requires a BS in a related science and 0–5 years in technical writing or regulatory roles.

Qualifikationen

  • Educational background as above.
  • 0-5 yrs experience in technical writing, quality/regulatory, or product development.
  • Utilizes MS Word, Excel, PowerPoint.
  • Understands change management and CAPA processes.
  • Soft skills including negotiation, collaboration, and stakeholder influence to drive compliance and meet timelines.
  • Knowledge of GxP and Regulatory requirements.
  • Experience navigating organizational complexity and cross-functional collaboration.

Aufgaben

  • Collaborates with stakeholders and maintains formula composition documentation as FLFs supporting the product lifecycle through development, transfer, and launch; and commercial formulations via change management.
  • Supports review and approval of formula/ingredient documentation to ensure accuracy, completeness, and traceability.
  • Learns regulations related to product formula and ingredient labeling for FLF.
  • Acts as key contact with project teams for product composition and labeling, driving cross-functional collaboration to maximize efficiency of documentation and authoring processes.
  • Manages documentation and data in systems (e.g. Veeva Quality and Veeva RIMS) and databases.
  • Develops understanding of Quality and Regulatory requirements to assist colleagues in formulation management.
  • Assists with authoring Regulatory CMC documentation related to composition.
  • May manage internal databases.
  • Follows GDP and cGMP regulatory SOPs and systems.

Kenntnisse

MS Word
MS Excel
MS PowerPoint
Technical writing
Change management
CAPA processes
GxP knowledge
Collaboration

Ausbildung

Bachelor of Science in Chemistry/Pharmacy/Biology or related science

Tools

Veeva Quality
Veeva RIMS

Jobbeschreibung

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.

Salary

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.

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.

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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