Job Information
Haleon Sr Manager, US Regulatory Operations & Compliance in Warren, New Jersey
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Theraflu, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
The Sr Manager, US Regulatory Operations & Compliance , is responsible for regulatory operational and compliance activities for the US, including Puerto Rico. The position is accountable for maintaining knowledge of evolving regulatory information systems and makes recommendations regarding potential application within the organization. Specifically, the position is accountable for compliance with evolving regulatory frameworks and relationships with the FDA related to reporting, establishment registration, drug listing, and document management.
In addition, this position is also responsible for identifying and supporting process improvements and data management according to company requirements. This includes serving as a primary contact for key cross-functional teams.
Role Responsibilities
Process Expertise: Responsible for developing, implementing and monitoring simple, compliant, fit for purpose processes. Includes responsibility for maintaining process documents in a controlled manner through available technology (eDMS).
System Administration: Create and Maintain repositories of current US regulatory documents in a controlled environment (i.e., eDMS, onsite and offsite storage); serve as official point of contact as US Regulatory Affairs (USRA) Administrator for Veeva Vault and any other systems needed; collaborate with USRA and cross functional team on technology solutions and serve as process expert on implementation
FDA Reporting Lead: Work with and help guide the team that compiles inputs for registration and reporting activities for FDA (i.e, Annual Reports, CARES reporting, etc); oversee process for all cross functional inputs, timelines for assigned reports, and any associated systems
Inspection Lead: Lead inspection-related activities including preparing for and leading regulatory inspections (e.g., able to directly lead internal and external inspectional activities).
Structured Product Labeling (SPL) and Registration Lead: SPL generation and review, as needed; oversee process, timelines, and any associated systems; oversee US establishment registrations to ensure current compliance
Training Coordination: Responsible for liaising with cross-functional teams to maintain USRA role-specific curricula; evaluate changes as needed; and support compliance
Lead Special Projects: Serve as Key Point of Contact/Lead as business needs arise (e.g., legal entity changes, business partnerships)
Ex-US Support: Support Certificate of Pharmaceutical Product (CPP) signatory needs on site as necessary
Performs related duties as assigned (remote or onsite as needed)
Why you?
Basic Qualifications:
Minimum 8 years of experience in Regulatory Affairs, Medical Affairs, Consumer Safety or related role with knowledge of pharma or OTC drug regulations.
Bachelor’s degree
Experience with compliance within US regulatory environment
Knowledge of medical or pharmaceutical terms
Demonstrated ability to lead projects or cross-functional teams
Strong organizational skills with out-of-the-box thinking.
Excellent oral and written communications skills, stakeholder management and enjoys working in multidisciplinary teams
Preferred Qualifications:
Advanced degree in business, quality or scientific disciplines
Experience at a large global pharmaceutical or OTC CPG company
Experience working on global teams
Project management experience
History of communication with FDA (including drug listing and establishment registrations, annual reports, inspections and audits)
Experience in document management, including Veeva
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk
Leading individual and team performance
Commitment to delivering high quality results, overcoming challenges, focusing on what matters, execution
Implementing change initiatives and leading change
Sustaining energy and well-being, building resilience in teams
Continuously looking for opportunities to learn, build skills and share learning both internally and externally
Developing people and building a talent pipeline
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally
Budgeting and forecasting, commercial and financial acumen
Location: This role is hybrid based in Warren, NJ
This job posting closes on April 4, 2025
Please save a copy of the job description, as this may be helpful to refer to once the advert closes.
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. The salary range for this role is: $132,856 to $182,667 plus an 18% bonus.
#Li-Hybrid
Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
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 and, in the US, we adhere to Affirmative Action principles. This ensures that 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.
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.
Accommodation Requests
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
Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.
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.
Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.