About the roleThe 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 SkillsEssential- 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.
LocationThis 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.BenefitsHaleon 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.
