Regulatory Affairs Associate at Halborn

Budapest, Budapest, Hungary

Halborn Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Consumer Health, PharmaceuticalsIndustries

Requirements

  • Knowledge of local (Hungary) regulatory requirements for consumer health products
  • Ability to collaborate with key stakeholders (e.g., marketing, quality, supply chain)
  • Strong analytical skills to identify and mitigate regulatory issues
  • Relationship-building skills with authorities and internal teams
  • Attention to detail for compliance with labelling, artwork, and promotional materials
  • Proactive mindset for innovative and rapid paths to market
  • Team-oriented approach to contribute to high-performing teams

Responsibilities

  • Manage preparation and submission of new regulatory documents, dossiers, and applications for product launches and maintenance in Hungary
  • Obtain all relevant authorizations to place Haleon products on the market as early as possible
  • Submit required new product files for Hungary
  • Perform tasks to maintain product licenses (e.g., notifications, variations, renewals) in compliance with legal requirements
  • Ensure deadlines for product launches, applications, and variations are met
  • Approve product labelling/artwork in line with Haleon and local legislation
  • Manage labelling text and packaging components for compliance with registered details and corporate information
  • Analyze regulatory issues, communicate with stakeholders, and develop mitigation plans
  • Contribute to high-performing local team and improve performance
  • Build relationships with stakeholders and represent Haleon according to company values
  • Manage compliance within defined portfolio/activity streams (e.g., CMC, quality, labelling, local regulations)
  • Collaborate with other functions to deliver innovations and value engineering projects
  • Support development of claims/advertising/promotion within regulations, addressing risks
  • Check and approve promotional and advertising materials for compliance with Haleon and local requirements
  • Obtain approvals from competent authorities for promotional materials, respond to comments, and ensure timely dissemination

Skills

Regulatory Affairs
Regulatory Submissions
Dossier Preparation
Compliance Management
Product Authorization
Stakeholder Collaboration
Promotional Materials

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters
2019Year Founded
$87.5MTotal Funding
SERIES_ACompany Stage
Cybersecurity, Financial ServicesIndustries
51-200Employees

Benefits

Health Insurance
Unlimited Paid Time Off
Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.
AI-powered social media bot farms could introduce new cyber threats.
Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.
The company offers high-level security audits and penetration testing for DeFi clients.
Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.
Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.
Tokenized real-world assets present new opportunities for Halborn's security solutions.

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