Regulatory Affairs Associate

Hello. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together were improving everyday health for billions of people. By growing and innovating our global portfolio of categoryleading brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum through a unique combination of deep human understanding and trusted science. Whats more were achieving it in a company that were in control an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt 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 were 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. Its an opportunity to be part of something special.

Join our dynamic team at Haleon 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 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.

Requirements

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

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

Language: Hungarian English (fluent written and verbal)

Qualifications and skills

We are looking for professionals with the required skills to achieve our goals:

• Minimum 1 year experience in Regulatory Affairs however this will vary between markets depending on availability of regulatory talent (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:

• 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.

Care to join us. Find out what life at Haleon is really like 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. Were 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.

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 let your recruiter know by providing them with a description of specific accommodations you are requesting. Well provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.