Cmc Operations Jobs in Georgia (NOW HIRING)

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 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.

Key responsibilities

• Information Management: 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.
• Operations Support: 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.
• CMC Support: 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).

Basic Qualifications:

• Educational Background: 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.

Preferred Qualifications:

• 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.

This role is located onsite, at our Richmond, VA facility.

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.

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.

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.

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.