Regulatory Affairs Manager

vor 1 Woche

Ingelheim am Rhein, Rheinland-Pfalz, Deutschland SCHOTT AG Vollzeit
About SCHOTT Pharma

SCHOTT Pharma is a leading developer of scientifically sound solutions for the pharmaceutical industry. Our team of experts works tirelessly to ensure medications are safe and easy to use for people around the world. With over 4,600 employees from more than 60 nations, we are committed to global healthcare and sustainability.

Your Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for managing regulatory aspects for product registrations and tackling global regulatory issues with agents and consultants. You will lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business.

Your Responsibilities
  • Manage regulatory aspects for product registrations and tackle global regulatory issues with agents and consultants
  • Lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business
  • Serve as the go-to advisor and trainer for internal SCHOTT-Pharma-specific regulatory topics, such as National Product Registrations and Drug Master Files (DMFs)
  • Roll out and oversee standards and central specifications for Dossier-structures across global markets for our customers
  • Ensure product-dossier compliance across our various sites for global registration procedures of our customers
  • Prepare response documents for official inquiries and provide statements for product registrations
  • Identify and define regulatory requirements for primary packaging systems and Medical Devices
  • Ensure we have the necessary standards, international pharmacopoeias, and guidelines at our fingertips
  • Evaluate and implement software tools in collaboration with IT to streamline regulatory processes
  • Play a key role in harmonizing the quality management system in the regulatory realm
Your Profile
  • A university degree in Science (biotechnology, pharmacy, pharmaceutical technology) is required, PhD is preferred
  • 5-10 years of professional experience in regulatory affairs or medical devices, with a focus on interfaces with quality management
  • Profound knowledge of the regulatory framework for parenteral packaging, combination products, and medical devices is essential
  • Proven skills in project management and ability to think interdisciplinary
  • Strong ability to act as a team player
What We Offer

SCHOTT's openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans, everything is geared to suit your goals and needs. Talent development is a top priority at SCHOTT Pharma AG & KGaA, Human Resources, Nadine Opp, and we are committed to becoming climate neutral by 2030.

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