Regulatory Affairs Associate

Join our dynamic team 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 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 with 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 the company in an appropriate manner according to company values, to present company policies and strategies.
• Manage compliance within defined portfolio/activity streams in line with company expectations - support key processes and ways of working (eg, in relation to 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 company and local requirements.
• Obtain necessary approvals from competent authorities for the promotional and advertising materials before dissemination in a timely manner. Respond to the authority’s 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 B.Sc in Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

Preferred level of education: B.Sc., M.Sc. 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