NA CMC FIO Operations Associate

Haleon • Augusta, GA

2d • Onsite

About The Position

The CMC and FIO Operations Associate is responsible for supporting the efficient execution, coordination, and compliance of North America activities for Chemistry, Manufacturing, and Controls (CMC) and Formulation Ingredient Operations (FIO). This role ensures the integrity, accuracy, and accessibility of regulatory and technical data, while facilitating cross-functional collaboration to support preparation of formulation documentation to support Regulatory labeling, CMC regulatory submissions, operational initiatives, and continuous improvement efforts. This role plays a critical part in ensuring the smooth operation of CMC and 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.

Requirements

• Bachelor’s degree in science or technical field, or 5+ years’ experience in a similar role with a demonstrated track record of achieving results.
• 2+ years of experience with technical documentation in a regulated environment.
• Working knowledge of MS Excel, document management systems (specifically Veeva), and database systems.
• Critical assessment of processes and systems, initiates improvements as required
• Demonstrated experience in navigating through organizational complexity and collaborating simultaneously with multiple teams.
• Excellent written and verbal communication skills.
• Communicates with adept business acumen with internal colleagues as well as third party suppliers.
• Attention to Detail - Be comfortable working in a faced-paced, dynamic environment maintaining a strong attention to detail.
• Organization and Time Management - Works independently on behalf of the team and quickly develops criteria to escalate issues for leadership notification and/or support
• 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.
• Continuous Improvement Mindset – Seeks out efficiencies in work process and raises recommendations to leadership for optimizations.

Responsibilities

• Supports data management and compliance for CMC and FIO documentation systems (e.g. Veeva). Resolve conflicts, ensures data integrity.
• Responsible for updates to other relevant databases to ensure accurate and compliant product information.
• Supports CMC, FIO, and other relevant business initiatives requiring compilation of data from Regulatory systems or dossiers.
• Manages local SOP and training programs.
• Supports process improvement initiatives and procedure updates.
• Manages and tracks CMC components for NDA Annual Reports and Canadian Annual Notifications by liaising with the manufacturing site Quality.
• Implement a tracking system to proactively inform the manufacturing sites of their annual report deliverables.
• Liases with QA, R&D, manufacturing sites, and Regulatory to obtain technical information to support FIO and CMC projects.
• Prepares and compiles FLFs/FCOMs and, with oversight, CMC regulatory submission documents.
• Comply with relevant Regulatory SOPs and systems.
• Follows Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).

Benefits

• competitive pay
• comprehensive benefits program
• generous 401(k) plan
• tuition reimbursement
• time off programs
• 6 months paid parental leave
• healthcare programs where the company pays for the majority of your medical coverage for you and your family
• discretionary bonus based on the achievement of key business performance
• other incentive/recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level