Senior Regulatory FIO Associate — Formulation & Labeling

gsknch

Richmond (VA)

Hybrid

USD 79,000 - 109,000

Full time

5 days ago
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Benefits offered by this job

401(k) plan
Tuition reimbursement
Paid parental leave
Healthcare benefits

Job summary

Haleon in Richmond, VA seeks a Senior Associate, NA Regulatory FIO to create and maintain Formulation and Labeling Forms across OTC Drugs, Dietary Supplements, Cosmetics and Medical Devices. You will liaise with Product Development, Regulatory Labeling and Site Technology/Quality to ensure compliant documentation throughout the product lifecycle.

This role emphasizes data quality, regulatory documentation, and cross-functional collaboration to drive compliant formulation management while

Qualifications

  • Bachelor of Science in Chemistry, Pharmacy, Biology or related science.
  • 0–5 years of experience in technical writing, quality/regulatory or product development.
  • Proficiency in MS Word, Excel and PowerPoint.
  • Knowledge of change management and CAPA processes.
  • Strong negotiation, collaboration and stakeholder influence to drive compliance and meet timelines.
  • Knowledge of GxP and Regulatory requirements.
  • Experience navigating organizational complexity and collaborating across teams.

Responsibilities

  • Collaborates with stakeholders and maintains formula documentation for FLFs across development, transfer and launch.
  • Supports review and approval of formula/ingredient documentation for accuracy and traceability.
  • Develops knowledge of regulations related to product formula and labeling for FLFs.
  • Engages with project teams as the key contact for product composition and labeling, driving cross-functional collaboration.
  • Manages documentation/data in systems (e.g., Veeva Quality, Veeva RIMS).
  • Gathers and applies Quality and Regulatory requirements to formulation management.
  • Assists with authoring Regulatory CMC documentation as needed.
  • May manage internal databases.
  • Complies with Regulatory SOPs and GDP/cGMP standards.

Skills

Technical writing
Regulatory knowledge
Stakeholder collaboration
GxP compliance
Document control

Education

B.S. in Chemistry/Pharmacy/Related Science

Tools

MS Word
Excel
PowerPoint

Job description

Haleon in Richmond, VA seeks a Senior Associate, NA Regulatory FIO to create and maintain Formulation and Labeling Forms across OTC Drugs, Dietary Supplements, Cosmetics and Medical Devices. You will liaise with Product Development, Regulatory Labeling and Site Technology/Quality to ensure compliant documentation throughout the product lifecycle.

This role emphasizes data quality, regulatory documentation, and cross-functional collaboration to drive compliant formulation management while

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