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Regulatory Affairs Lead Austria

Regulatory Affairs Lead Austria

OpellaWien, Republic Of Austria, AT
Vor 16 Stunden
Stellenbeschreibung

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission is to bring health in people's hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world's most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at

About the job :

  • The Regulatory Affairs Lead Austria is responsible for leading the local CHC Regulatory team in Austria, ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment.

Main responsibilities :

  • Regulatory Compliance : Ensure product packaging and information match current licenses, Marketing Authorizations reflect updated safety data, and all local regulatory activities (SOPs, training, databases) comply with corporate and national standards.
  • Portfolio Management : Lead the review and approval of promotional and non-promotional materials, manage local regulatory maintenance, prepare dossiers, support OTC switches, and contribute to local regulatory strategies and business development.
  • Talent & Leadership : Supervise and develop a local Regulatory Affairs student, align priorities with business goals, ensure high-quality submissions, manage resources and budget, and contribute to the Western Europe RA Leadership team.
  • Collaboration & Partnerships : Build and maintain strong relationships with internal and external stakeholders, fostering cross-functional collaboration in line with Opella's values.
  • Health Authority Engagement : Act as the main contact for local regulatory authorities, build credibility, and position Opella as a trusted partner while providing regulatory thought leadership.
  • Regulatory Intelligence : Monitor emerging regulatory requirements, assess their impact, and ensure strategic alignment and communication with relevant stakeholders.
  • Innovation & Risk Management : Support innovative regulatory pathways, identify risks and mitigation strategies, and coordinate the approval and implementation of risk management plans and educational materials.
  • About you :

  • Experience : Min. 3 years of Regulatory Affairs experience in Austria for consumer healthcare medicinal products.
  • Skills : Previously nominated as responsible person for review of CHC promotional material towards Austrian Health Authority. Team player, Challenger mindset, Open for changes.
  • Education : Master's degree in science is preferable.
  • Languages : German as mother tongue and fluent English.
  • Why us?

    At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

    We Are Challengers.

    We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things :

    All In Together : We keep each other honest and have each other's backs.

    Courageous : We break boundaries and take thoughtful risks with creativity.

    Outcome-Obsessed : We are personally accountable, driving sustainable impact and results with integrity.

    Radically Simple : We strive to make things simple for us and simple for consumers, as it should be.

    Join us on our mission. Health. In your hands.

    LI-HYBRID

    Jobalert für diese Suche erstellen

    Austria • Wien, Republic Of Austria, AT

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