Operations and Process Lead - Regulatory Product Owner

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 Operations and Support Lead supports the Regulatory Affairs teams with operational management and use of Haleon’s regulatory systems to carry out the business responsibilities of the respective functions. The role requires engagement with relevant cross-functional working groups and management of key stakeholders.

The Operations & Support Lead is responsible to act as a conduit to system end users and Tech colleagues to enable development and enhancement of solutions for the assigned business domains. Key activities include project management, data access enablement, metrics, reporting and analysis, dashboard and interface design, process mapping and training support.

Key responsibilities

The Operations & Support Lead will be accountable for:

• Ensuring GxP requirements and inspection readiness are maintained and current.
• Ensuring compliance and validation documentation are appropriately maintained for applicable systems.
• Supporting Audit/Assessment/Inspection readiness and leading or participating in internal audits and/or external inspections as needed.
• Collecting, maintaining and prioritizing user requirements for applicable applications and solutions.
• Development and management of System Access Plans and user account oversight activities.
• Contribution to Business Continuity planning and execution of BCP activities.
• Support of end users that require functionality/capability assistance and/or training.
• Working in close collaboration with business owners and stakeholders to provide processes and solutions that support business processes and fulfil regulatory requirements.
• Managing a team of Support Specialists that provide services to business partners.
• Creating the climate for continuous improvement way of working and optimize processes with the most appropriate solution considering quality, cost and business needs.
• Managing the preparation, maintenance and execution of user acceptance testing as required. Identify opportunities for testing efficiencies and confirm that acceptance criteria have been met from the business perspective. 
• Providing input for the development, enhancement, implementation and maintenance of all impacted written standards and training content.
• Oversight of applicable vendor/contract staff for relevant projects and implementations.
• Plan, monitor and manage projects from initiation through completion. Leads or coordinates project planning, resourcing, reporting and troubleshooting to ensure deliverables meet requirements and timelines.
• Working in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems, processes and downstream outputs.
• Accountable for resolving and escalating applicable incidents, acting 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.
• Provide input as SME for the development, enhancement, implementation and maintenance of all impacted written standards and required training content.

Qualifications and skills

Essential

• Bachelor’s degree in life sciences or information technology or other related area.
• 7 years pharmaceutical industry and/or consumer goods industry knowledge and experience with minimum 5 years in Regulatory Affairs.
• Experience leading teams and managing people.
• Experience with validated document management systems.
• Proven understanding of the Regulatory processes and major agency regulations like FDA, EMA, PMDA, MFDS and NMPA, ICH GxP regarding systems validation and documentation.
• Track record of success in continuous improvement, innovative work practices and driving change.
• 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.

Preferred

• Technical background and computer proficiency in a variety of regulatory, clinical or related systems, reporting capabilities and familiarity with MS O365.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Ability to identify opportunities for process and compliance improvements.
• Enhanced 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

 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.