Are you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the business? If so, this role could be an ideal opportunity to explore.
You will be responsible for the following contributions:
Regulatory Affairs:
Application
- Understand FDA Promo Application schedules by category and ensure proper timing of submissions to secure approval at the earliest possible date.
- Initiate Application: Fill out FDA Promo Permit Application Form. Route the form to TM and RA for final approval. Ensure to secure complete supporting documents from TM, Brand and RA.
- Submit Completed Application Form with the necessary supporting documents to FDA via email. Process payment with FDA for application.
- Monitor progress of application with the FDA either electronically or in person. Make the necessary follow thru. Raise with RA any help needed.
- Update the cross functional team once FDA releases approval
Monitoring and Documentation
- Monitor all promo permits active and alert team if there are promo permits expiring and apply for renewal if necessary.
- Proper documentation and safekeeping of documents to create efficiency way forward.
Marketing (Artwork):
- Accountable for delivery for all artwork creation and approval activities; Includes creation of project plans and timelines, deliverable assignments, status tracking, escalations
- Accountable for end-to-end delivery of artwork transition projects, including coordinating all processes and partnering with marketing, trade marketing, and supply chain until artwork transition has been fully implemented.
- Ensures GxP process compliance to deliver on-time and accurate artwork; Delivers training and guidance to functions; Acts as a subject matter expert in the artwork management system
- Manages the resolution of technical and Studio queries to meet project milestones; Attends project meetings and communicates with Studio counterparts, as required
- May act as a proxy for manufacturing sites or internal functions without direct access to the artwork management system
- Offers recommendations and business case for procedural and service improvements and enhancements; Supports implementation of process improvements, as applicable
Skills and experience
- Bachelor’s degree or degree in a relevant field
- 2+ years business experience
- Ability to deliver operational excellence and coordinate complex tasks
- Basic use of Microsoft tools
- Problem solving
- Strong stakeholder management
- Collaboration
- Project management and issue mitigation/escalation
Desired skills
- Experience with SAP, Veeva highly regarded but not essential
- Experience in 3 of the below:
- Regulatory affairs
- artwork coordination
- packaging design
- external studio
- printers
- logistics
- manufacturing
- GxP processes
- FMCG or other related supply operations
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.