Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve 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 its 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.

Regulatory Affairs Associate

About the role

Join our dynamic team in Budapest Hungary as a Regulatory Affairs Associate where you will manage the preparation and submission of regulatory documents to ensure our products comply with local regulations and reach the market efficiently. You will collaborate with key stakeholders manage the submission of the regulatory related activities to ensure timely approval and implementation and support the development of promotional materials all while contributing to a high-performing team.

This is a temporary role to cover for a maternity leave.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Key Responsibilities & Accountability

• Manage preparation of new regulatory documents dossiers and applications to enable new products to be launched and maintained in market with the correct alignment and compliance to regulations proactively seeking innovative and rapid path to market.

• Obtain all relevant authorizations necessary to place Haleon products in Hungary ensures that these are received as early as possible.

• Submit all required new product files developed for Hungary.

• Perform all specific tasks (update registration information of products by submitting notifications variations and renewals etc) required in order to gain and maintain product licenses up-to-date valid and in compliance with the legal requirements in Hungary.

• Ensure the deadlines for product launch new product application and variations submissions are kept.

• Approve the products labelling/artwork in line Haleon and local legislation requirements.

• Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information.

• Analyze regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate so we can deliver science that is robust and aligned with business needs.

• Actively contributes to the activity of a high performing local team including looking for ways to improve performance.

• Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values to present Haleon policies and strategies.

• Manage compliance within defined portfolio/activity streams in line with Haleon expectations - support key processes and ways of working (eg in relation to Haleon CMC quality product labelling requirements as well as local regulations)

• Work together with other functions (eg marketing quality and supply chain) to deliver innovations and value engineering projects.

• Support the development of the strongest claims/advertising and promotion possible within the regulations ensuring risks are appropriately addressed and communicated.

• Check and approve promotional and advertising materials ensuring that materials comply with Haleon and local requirements.

• Obtain necessary approvals from competent authorities for the promotional and advertising materials before dissemination in a timely manner. Respond to the authoritys comments offer supporting evidence and argumentation for our claims to obtain timely approval.

• Proactively managing the impact of regulatory changes within defined scope of responsibility on the business

• Maintain required regulatory compliance databases systems and processes.

• Maintain high levels of knowledge on the science of products within defined portfolio.

Why you

Basic Qualifications:

• Minimum level of education: BA or in Life science/Pharmaceutically related science (Chemistry Pharmacy Biochemistry Biology Medical Engineering)

• Language: Hungarian English (fluent written and verbal)

• Minimum 1 year experience in Regulatory Affairs (Regulatory clearance is a pre-requisite of any product marketing. Compliance to regulatory requirements and management of health authorities is essential to corporate compliance and product portfolio/sales maintenance)

• Planning and organization skills

• Negotiation skills --experience in working with different external Regulatory Authorities

Preferred Qualifications and skills:

• Preferred level of education: . . or equivalent in Regulatory Affairs Pharmacy

• The ability to effectively communicate and negotiate in relation to technical information and regulations is key.

• Strategic thinking

• Working knowledge of dossier requirements CTD eCTD NeeS.

• Strong results driven abilities.

• Excellent interpersonal time management organizational and communication skills

Please save a copy of the job description as this may be helpful to refer to once the advert closes.

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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. Its 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. Well 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 (@). If you are not sure whether the email you received is from Haleon please get in touch.