Operations and Support Associate - Regulatory

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.

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, 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 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.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About the role

The Operations and Support Associate- Regulatory, supports the Regulatory Affairs teams with operational use of Haleon’s regulatory systems to carry out the business functions of regulatory affairs associated capabilities.

The role will involve interaction with business users and Tech partners as a primary support role, including business user support, system enhancements, training, communications, and testing. User support includes request and issue resolution and general user assistance.

Role Responsibilities

• Provides input and support on queries from business regarding regulatory and related systems functionality as assigned.
• Gather user requirements and identify impacts on other components of the system environment.
• Work in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems. •Accountable for resolving and escalating applicable incidents, act upon user requests in collaboration with Tech colleagues as necessary.
• Contribute to discussions with business stakeholders to understand business requirements, enhancements, and product roadmap, support the documentation of internal processes, user requirements, written standards, communications and training development and content.
• Participate in all aspects of informal testing and formal user acceptance testing for releases and changes.
• Support internal and external audits and HA and LP inspection requests as needed. Provide user guidance and support including access and incident management tasks.
• Responsible for management of organization, personnel and product profiles. •Responsible for configuration of PV reporting rules for Health Authorities and License Partners.
• Provide consultation and troubleshooting support for user issues, document management, system management and other problems.

Basic Qualifications:

• Bachelor’s degree in life sciences or information technology or other related area.
• 8-10 minimum years pharmaceutical industry and/or consumer goods industry knowledge and experience.
• Experience with Veeva Vault RIMS configuration or equivalent RIM systems.
• Experience in regulatory operations, submissions or publishing systems.
• Experience in regulatory data management and lifecycle processes.
• Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment.
• Strong troubleshooting and root-cause analysis skills, with the ability to manage & support tickets.
• Knowledge in Regulatory requirements and submissions across EU, US and Global markets.
• Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus.
• Knowledge of JIRA backlog and requirement management
• Support User testing and execution oversight.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Customer service orientation and ability to communicate professionally to diverse cross-functional non-technical and technical audiences.
• Experience in work requiring attention to detail and excellent follow-up.
• Self-motivated, able to resolve issues with cross-functional teams with minimal supervision.

Location - this role is based in: Hyderabad Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Diversity, Equity and Inclusion

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.

Job Posting End Date

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.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

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.